EdemaPhase 4NCT05466604
Comparison of Hyaluronidase and Dexametasone in Reduction of Postoperative Edema
A Phase 4 study testing Hyaluronidase Injection mesomedica and Dexamethasone dekort in people with Edema and Pain, run by Hacettepe University at 2 sites in 2 countries.
Trial summary
The present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. For this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Hyaluronidase Injection mesomedica and Dexamethasone dekort
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2019to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- symmetrical mandibular wisdom teeth with bone retention
- patients who are signed informed consent and acceptance of study involvement forms
Who cannot join
- existence of any systemic disease
- existence of any periodical drug intake
- existence of difference in operation times of right and left impacted wisdom teeth extractions more than 5 minutes
- existence of pregnancy
- existence of breastfeeding
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Comparison of the Effects of Hyaluronidase and Dexamethasone on Reduction of Postoperative Edema in Impacted Wisdom Teeth Surgery
The present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. For this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. All measurements and evaluations were performed before and 1, 2, 3, and 7 days later the operation.
- Conditions
- Edema, Pain, Trismus, Infection, Surgical Site
- Being tested
- Hyaluronidase Injection mesomedica, Dexamethasone dekort
- Keywords
- postoperative edema, wisdom teeth, trismus, pain control, wound infection
- Medical subject headings
- Edema, Pain, Trismus, Surgical Wound Infection, Agnosia, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronidase Injection mesomedicaDrug
injection of 150 IU hyaluronidase to perioperative region, submucosally.
Dexamethasone dekortDrug
injection of 8 mg dexamethasone to perioperative region, submucosally.
| Study group | Role | What they receive |
|---|---|---|
| hyaluronidase | Experimental | Not described Receives: Drug: Hyaluronidase Injection mesomedica |
| hyaluronidase control | No intervention | Not described |
| dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone dekort |
| dexamethasone control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase experimental group
preoperative edema amount was subtracted from edema amount in 1. day in hyaluronidase experimental group
Measured: postoperative 1. day
evaluation of the increase of edema in postoperative 2. day using a measuring tape in hyaluronidase experimental group
preoperative edema amount was subtracted from edema amount in 2. day in hyaluronidase experimental group
Measured: postoperative 2. day
evaluation of the increase of edema in postoperative 3. day using a measuring tape in hyaluronidase experimental group
preoperative edema amount was subtracted from edema amount in 3. day in hyaluronidase experimental group
Measured: postoperative 3. day
evaluation of the increase of edema in postoperative 7. day using a measuring tape in hyaluronidase experimental group
preoperative edema amount was subtracted from edema amount in 7. day in hyaluronidase experimental group
Measured: postoperative 7. day
evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase control group
preoperative edema amount was subtracted from edema amount in 1. day in hyaluronidase control group
Measured: postoperative 1. day
evaluation of the increase of edema in postoperative 2. day using a measuring tape in hyaluronidase control group
preoperative edema amount was subtracted from edema amount in 2. day in hyaluronidase control group
Measured: postoperative 2. day
evaluation of the increase of edema in postoperative 3. day using a measuring tape in hyaluronidase control group
preoperative edema amount was subtracted from edema amount in 3. day in hyaluronidase control group
Measured: postoperative 3. day
evaluation of the increase of edema in postoperative 7. day using a measuring tape in hyaluronidase control group
preoperative edema amount was subtracted from edema amount in 7. day in hyaluronidase control group
Measured: postoperative 7. day
evaluation of the increase of edema in postoperative 1. day using a measuring tape in dexamethasone experimental group
preoperative edema amount was subtracted from edema amount in 1. day in dexamethasone experimental group
Measured: postoperative 1. day
evaluation of the increase of edema in postoperative 2. day using a measuring tape in dexamethasone experimental group
preoperative edema amount was subtracted from edema amount in 2. day in dexamethasone experimental group
Measured: postoperative 2. day
evaluation of the increase of edema in postoperative 3. day using a measuring tape in dexamethasone experimental group
preoperative edema amount was subtracted from edema amount in 3. day in dexamethasone experimental group
Measured: postoperative 3. day
evaluation of the increase of edema in postoperative 7. day using a measuring tape in dexamethasone experimental group
preoperative edema amount was subtracted from edema amount in 7. day in dexamethasone experimental group
Measured: postoperative 7. day
evaluation of the increase of edema in postoperative 1. day using a measuring tape in dexamethasone control group
preoperative edema amount was subtracted from edema amount in 1. day in dexamethasone controlgroup
Measured: postoperative 1. day
evaluation of the increase of edema in postoperative 2. day using a measuring tape in dexamethasone control group
preoperative edema amount was subtracted from edema amount in 2. day in dexamethasone controlgroup
Measured: postoperative 2. day
evaluation of the increase of edema in postoperative 3. day using a measuring tape in dexamethasone control group
preoperative edema amount was subtracted from edema amount in 3. day in dexamethasone controlgroup
Measured: postoperative 3. day
evaluation of the increase of edema in postoperative 7. day using a measuring tape in dexamethasone control group
preoperative edema amount was subtracted from edema amount in 7. day in dexamethasone controlgroup
Measured: postoperative 7. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 1. day using a measuring tape
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 1. day
Measured: postoperative 1. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 2. day using a measuring tape
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 2. day
Measured: postoperative 2. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 3. day using a measuring tape
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 3. day
Measured: postoperative 3. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 7. day using a measuring tape
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 7. day
Measured: postoperative 7. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 1. day using a measuring tape
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 1. day
Measured: postoperative 1. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 2. day using a measuring tape
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 2. day
Measured: postoperative 2. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 3. day using a measuring tape
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 3. day
Measured: postoperative 3. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 7. day using a measuring tape
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 7. day
Measured: postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 1. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
Measured: postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 2. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
Measured: postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 3. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
Measured: postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 4. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
Measured: postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 5. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
Measured: postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 6. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
Measured: postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 7. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
Measured: postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 1. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
Measured: postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 2. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
Measured: postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 3. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
Measured: postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 4. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
Measured: postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 5. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
Measured: postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 6. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
Measured: postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 7. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
Measured: postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 1. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
Measured: postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 2. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
Measured: postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 3. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
Measured: postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 4. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
Measured: postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 5. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
Measured: postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 6. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
Measured: postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 7. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
Measured: postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 1. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
Measured: postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 2. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
Measured: postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 3. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
Measured: postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 4. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
Measured: postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 5. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
Measured: postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 6. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
Measured: postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 7. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
Measured: postoperative 7. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group preoperatively.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: preoperative
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 1. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 1. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 2. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 2. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 3. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 3. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 7. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 7. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group preoperatively.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: preoperative
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 1. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 1. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 2. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 2. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 3. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 3. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 7. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 7. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group preoperatively.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: preoperative
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 1. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 1. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 2. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 2. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 3. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 3. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 7. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 7. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group preoperatively.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: preoperative
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 1. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 1. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 2. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 2. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 3. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 3. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 7. day.
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
Measured: postoperative 7. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group preoperatively.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: preoperative
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 1. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 1. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 2. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 2. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 3. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 3. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 7. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 7. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group preoperatively.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: preoperative
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 1. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 1. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 2. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 2. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 3. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 3. day
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 7. day.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 7. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group preoperatively.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: preoperative
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 1. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 1. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 2. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 2. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 3. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 3. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 7. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 7. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group preoperatively.
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: preoperatively
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 1. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 1. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 2. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 2. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 3. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 3. day
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 7. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Measured: postoperative 7. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Dec 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koç, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466604
- Sponsor's protocol ID
- YDU/2019//74-921
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.
PubMed 39215323
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Hyaluronidase and Dexamethasone on Reduction of Postoperative Edema in Impacted Wisdom Teeth Surgery
- ClinicalTrials.gov ID
- NCT05466604
- Acronym / sponsor ID
- YDU/2019//74-921
- Conditions
- Edema, Pain, Trismus, Infection, Surgical Site
- Keywords
- postoperative edema, wisdom teeth, trismus, pain control, wound infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. For this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. All measurements and evaluations were performed before and 1, 2, 3, and 7 days later the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| hyaluronidase | Experimental | Drug: Hyaluronidase Injection mesomedica |
| hyaluronidase control | No intervention | – |
| dexamethasone | Experimental | Drug: Dexamethasone dekort |
| dexamethasone control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- symmetrical mandibular wisdom teeth with bone retention
- patients who are signed informed consent and acceptance of study involvement forms
Key exclusion criteria (5 listed)
- existence of any systemic disease
- existence of any periodical drug intake
- existence of difference in operation times of right and left impacted wisdom teeth extractions more than 5 minutes
- existence of pregnancy
- existence of breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronidase Injection mesomedicainjection of 150 IU hyaluronidase to perioperative region, submucosally. | Drug | hyaluronidase |
| Dexamethasone dekortinjection of 8 mg dexamethasone to perioperative region, submucosally. | Drug | dexamethasone |
Primary outcome
evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase experimental group
Time frame: postoperative 1. day
preoperative edema amount was subtracted from edema amount in 1. day in hyaluronidase experimental group
evaluation of the increase of edema in postoperative 2. day using a measuring tape in hyaluronidase experimental group
Time frame: postoperative 2. day
preoperative edema amount was subtracted from edema amount in 2. day in hyaluronidase experimental group
evaluation of the increase of edema in postoperative 3. day using a measuring tape in hyaluronidase experimental group
Time frame: postoperative 3. day
preoperative edema amount was subtracted from edema amount in 3. day in hyaluronidase experimental group
evaluation of the increase of edema in postoperative 7. day using a measuring tape in hyaluronidase experimental group
Time frame: postoperative 7. day
preoperative edema amount was subtracted from edema amount in 7. day in hyaluronidase experimental group
evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase control group
Time frame: postoperative 1. day
preoperative edema amount was subtracted from edema amount in 1. day in hyaluronidase control group
evaluation of the increase of edema in postoperative 2. day using a measuring tape in hyaluronidase control group
Time frame: postoperative 2. day
preoperative edema amount was subtracted from edema amount in 2. day in hyaluronidase control group
evaluation of the increase of edema in postoperative 3. day using a measuring tape in hyaluronidase control group
Time frame: postoperative 3. day
preoperative edema amount was subtracted from edema amount in 3. day in hyaluronidase control group
evaluation of the increase of edema in postoperative 7. day using a measuring tape in hyaluronidase control group
Time frame: postoperative 7. day
preoperative edema amount was subtracted from edema amount in 7. day in hyaluronidase control group
evaluation of the increase of edema in postoperative 1. day using a measuring tape in dexamethasone experimental group
Time frame: postoperative 1. day
preoperative edema amount was subtracted from edema amount in 1. day in dexamethasone experimental group
evaluation of the increase of edema in postoperative 2. day using a measuring tape in dexamethasone experimental group
Time frame: postoperative 2. day
preoperative edema amount was subtracted from edema amount in 2. day in dexamethasone experimental group
evaluation of the increase of edema in postoperative 3. day using a measuring tape in dexamethasone experimental group
Time frame: postoperative 3. day
preoperative edema amount was subtracted from edema amount in 3. day in dexamethasone experimental group
evaluation of the increase of edema in postoperative 7. day using a measuring tape in dexamethasone experimental group
Time frame: postoperative 7. day
preoperative edema amount was subtracted from edema amount in 7. day in dexamethasone experimental group
evaluation of the increase of edema in postoperative 1. day using a measuring tape in dexamethasone control group
Time frame: postoperative 1. day
preoperative edema amount was subtracted from edema amount in 1. day in dexamethasone controlgroup
evaluation of the increase of edema in postoperative 2. day using a measuring tape in dexamethasone control group
Time frame: postoperative 2. day
preoperative edema amount was subtracted from edema amount in 2. day in dexamethasone controlgroup
evaluation of the increase of edema in postoperative 3. day using a measuring tape in dexamethasone control group
Time frame: postoperative 3. day
preoperative edema amount was subtracted from edema amount in 3. day in dexamethasone controlgroup
evaluation of the increase of edema in postoperative 7. day using a measuring tape in dexamethasone control group
Time frame: postoperative 7. day
preoperative edema amount was subtracted from edema amount in 7. day in dexamethasone controlgroup
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 1. day using a measuring tape
Time frame: postoperative 1. day
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 1. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 2. day using a measuring tape
Time frame: postoperative 2. day
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 2. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 3. day using a measuring tape
Time frame: postoperative 3. day
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 3. day
evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 7. day using a measuring tape
Time frame: postoperative 7. day
edema increase amount of hyaluronidase experimental group was compared with that of hyaluronidase control group in postoperative 7. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 1. day using a measuring tape
Time frame: postoperative 1. day
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 1. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 2. day using a measuring tape
Time frame: postoperative 2. day
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 2. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 3. day using a measuring tape
Time frame: postoperative 3. day
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 3. day
evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 7. day using a measuring tape
Time frame: postoperative 7. day
edema increase amount of dexamethasone experimental group was compared with that of dexamethasone control group in postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 1. day
Time frame: postoperative 1. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 2. day
Time frame: postoperative 2. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 3. day
Time frame: postoperative 3. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 4. day
Time frame: postoperative 4. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 5. day
Time frame: postoperative 5. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 6. day
Time frame: postoperative 6. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 7. day
Time frame: postoperative 7. day
pain intensity of the patients in hyaluronidase experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 1. day
Time frame: postoperative 1. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 2. day
Time frame: postoperative 2. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 3. day
Time frame: postoperative 3. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 4. day
Time frame: postoperative 4. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 5. day
Time frame: postoperative 5. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 6. day
Time frame: postoperative 6. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 7. day
Time frame: postoperative 7. day
pain intensity of the patients in hyaluronidase control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 1. day
Time frame: postoperative 1. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 2. day
Time frame: postoperative 2. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 3. day
Time frame: postoperative 3. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 4. day
Time frame: postoperative 4. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 5. day
Time frame: postoperative 5. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 6. day
Time frame: postoperative 6. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 7. day
Time frame: postoperative 7. day
pain intensity of the patients in dexamethasone experimental group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 1. day
Time frame: postoperative 1. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 1. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 2. day
Time frame: postoperative 2. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 2. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 3. day
Time frame: postoperative 3. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 3. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 4. day
Time frame: postoperative 4. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 4. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 5. day
Time frame: postoperative 5. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 5. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 6. day
Time frame: postoperative 6. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 6. day
evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 7. day
Time frame: postoperative 7. day
pain intensity of the patients in dexamethasone control group was assessed using visual analog scale (VAS) and daily count of NSAİ drug intake in postoperative 7. day
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group preoperatively.
Time frame: preoperative
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 1. day.
Time frame: postoperative 1. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 2. day.
Time frame: postoperative 2. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 3. day.
Time frame: postoperative 3. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 7. day.
Time frame: postoperative 7. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group preoperatively.
Time frame: preoperative
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 1. day.
Time frame: postoperative 1. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 2. day.
Time frame: postoperative 2. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 3. day.
Time frame: postoperative 3. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 7. day.
Time frame: postoperative 7. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group preoperatively.
Time frame: preoperative
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 1. day.
Time frame: postoperative 1. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 2. day.
Time frame: postoperative 2. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 3. day.
Time frame: postoperative 3. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 7. day.
Time frame: postoperative 7. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group preoperatively.
Time frame: preoperative
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 1. day.
Time frame: postoperative 1. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 2. day.
Time frame: postoperative 2. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 3. day.
Time frame: postoperative 3. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 7. day.
Time frame: postoperative 7. day
amount of trismus is revealed measuring the distance between the tips of incisal edges of mandibular and maxillary right first incisors using a ruler
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group preoperatively.
Time frame: preoperative
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 1. day.
Time frame: postoperative 1. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 2. day.
Time frame: postoperative 2. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 3. day.
Time frame: postoperative 3. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 7. day.
Time frame: postoperative 7. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group preoperatively.
Time frame: preoperative
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 1. day.
Time frame: postoperative 1. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 2. day.
Time frame: postoperative 2. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 3. day.
Time frame: postoperative 3. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 7. day.
Time frame: postoperative 7. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group preoperatively.
Time frame: preoperative
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 1. day
Time frame: postoperative 1. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 2. day
Time frame: postoperative 2. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 3. day
Time frame: postoperative 3. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 7. day
Time frame: postoperative 7. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group preoperatively.
Time frame: preoperatively
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 1. day
Time frame: postoperative 1. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 2. day
Time frame: postoperative 2. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 3. day
Time frame: postoperative 3. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 7. day
Time frame: postoperative 7. day
existence of infection signs were determined using physical examination method. if the count of + signs are more than half of total amount of determined signs, the evaluation is accepted as (+) infected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 39215323Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronidase Injection mesomedica and Dexamethasone dekort in people with Edema and Pain, run by Hacettepe University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase experimental group (time frame: postoperative 1. day). The study lists 92 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.