Tooth, ImpactedNCT06280014
Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery
A study testing Surgery of impacted mandibular wisdom teeth in people with Tooth, Impacted and Tooth Diseases, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted, Tooth Diseases
- What is being tested?
- Surgery of impacted mandibular wisdom teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2022to 25 Sep 2023
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with bilateral fully impacted mandibular wisdom teeth
Who cannot join
- Patients were excluded from the study if they did not understand the clinical procedures of the study,
- Had allergies or intolerance to any of the substances used in the study,
- Patients on anticoagulant or psychiatric treatment,
- Pregnant or breastfeeding,
- Patients using oral contraceptiveswere,
- Diabetic,
- Patients with periodontal disease or active infection,
- Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Pain, Edema and Trismus in Impacted Wisdom Dental Surgery
This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated.
Read the detailed description
The aim of this study; to compare the effects of dexketoprofen and mefanamic acid on pain, edema and trismus after lower impacted wisdom teeth surgery. 60 impacted wisdom teeth in 30 healthy individuals who applied to Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery with an indication for extraction of impacted lower wisdom teeth were included in the study. 60 impacted wisdom teeth belonging to individuals were randomly divided into two groups (A and B). In a randomized, controlled, double-blind study, dexketoprofen (A) and mefanamic acid (B) were given to patients immediately after surgery. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days. For the evaluation of edema, the facial measurements of the patients before the operation were recorded and repeated on the 2nd and 7th postoperative days. Preoperative maximum mouth opening measurement for trismus assessment was repeated on the 2nd and 7th postoperative days and recorded.
- Conditions
- Tooth, Impacted, Tooth Diseases
- Being tested
- Surgery of impacted mandibular wisdom teeth
- Keywords
- impacted wisdom teeth, dexketoprofen, mefenamic acid
- Medical subject headings
- Tooth, Impacted, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of impacted mandibular wisdom teethProcedure or surgery
Also called Surgery of impacted molar teeth
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. After extraction of impacted wisdom tooth, the patient was given mefenamic acid as a medication.
Surgery of impacted mandibular wisdom teethProcedure or surgery
Also called Surgery of impacted molar teeth
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. After extraction of impacted wisdom tooth, the patient was dexketoprofen as a medication.
| Study group | Role | What they receive |
|---|---|---|
| Mefenamic acid was used to see post operative effects after extraction of 3rd molar in study group | Experimental | In this study of 30 patients, 22 females and 8 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and mefenamic acid was used as a drug to see post operative effects after extraction of impacted 3rd molars in the study group. Receives: Procedure: Surgery of impacted mandibular wisdom teeth |
| Dexketoprofen was used to see post operative effects after extraction of 3rd molar in control group | Placebo comparator | Bilateral impacted wisdom teeth of the patients were randomly selected. After the tooth in the experimental group was extracted, the other impacted wisdom tooth was selected as the control group and dexketoprofen was used as a drug to see post operative effects. Receives: Procedure: Surgery of impacted mandibular wisdom teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening measurements
The distance between the incisals of the patient's central teeth at maximal mouth opening.
Measured: 0-28 days
Facial edema
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
Measured: 0-28 days
Visual Analog Scale
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Jan 2022
- Primary completion20 Feb 2022
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280014
- Sponsor's protocol ID
- YYU-09/15.12.2021
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Pain, Edema and Trismus in Impacted Wisdom Dental Surgery
- ClinicalTrials.gov ID
- NCT06280014
- Acronym / sponsor ID
- YYU-09/15.12.2021
- Conditions
- Tooth, Impacted, Tooth Diseases
- Keywords
- impacted wisdom teeth, dexketoprofen, mefenamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 28 Feb 2024 (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.
This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated.
Detailed description
The aim of this study; to compare the effects of dexketoprofen and mefanamic acid on pain, edema and trismus after lower impacted wisdom teeth surgery. 60 impacted wisdom teeth in 30 healthy individuals who applied to Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery with an indication for extraction of impacted lower wisdom teeth were included in the study. 60 impacted wisdom teeth belonging to individuals were randomly divided into two groups (A and B). In a randomized, controlled, double-blind study, dexketoprofen (A) and mefanamic acid (B) were given to patients immediately after surgery. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days. For the evaluation of edema, the facial measurements of the patients before the operation were recorded and repeated on the 2nd and 7th postoperative days. Preoperative maximum mouth opening measurement for trismus assessment was repeated on the 2nd and 7th postoperative days and recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mefenamic acid was used to see post operative effects after extraction of 3rd molar in study group | Experimental | Procedure: Surgery of impacted mandibular wisdom teethIn this study of 30 patients, 22 females and 8 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and mefenamic acid was used as a drug to see post operative effects after extraction of impacted 3rd molars in the study group. |
| Dexketoprofen was used to see post operative effects after extraction of 3rd molar in control group | Placebo comparator | Procedure: Surgery of impacted mandibular wisdom teethBilateral impacted wisdom teeth of the patients were randomly selected. After the tooth in the experimental group was extracted, the other impacted wisdom tooth was selected as the control group and dexketoprofen was used as a drug to see post operative effects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers with bilateral fully impacted mandibular wisdom teeth
Key exclusion criteria (8 listed)
- Patients were excluded from the study if they did not understand the clinical procedures of the study,
- Had allergies or intolerance to any of the substances used in the study,
- Patients on anticoagulant or psychiatric treatment,
- Pregnant or breastfeeding,
- Patients using oral contraceptiveswere,
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 |
|---|---|---|
| Surgery of impacted mandibular wisdom teethAlso: Surgery of impacted molar teethAll surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. After extraction of impacted wisdom tooth, the patient was given mefenamic acid as a medication. | Procedure or surgery | Mefenamic acid was used to see post operative effects after extraction of 3rd molar in study group |
| Surgery of impacted mandibular wisdom teethAlso: Surgery of impacted molar teethAll surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. After extraction of impacted wisdom tooth, the patient was dexketoprofen as a medication. | Procedure or surgery | Dexketoprofen was used to see post operative effects after extraction of 3rd molar in control group |
Primary outcome
Mouth opening measurements
Time frame: 0-28 days
The distance between the incisals of the patient's central teeth at maximal mouth opening.
Facial edema
Time frame: 0-28 days
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
Visual Analog Scale
Time frame: 0-28 days
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
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 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery of impacted mandibular wisdom teeth in people with Tooth, Impacted and Tooth Diseases, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mouth opening measurements (time frame: 0-28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.