PainPhase 4NCT03745599
Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life
A Phase 4 study testing Diclofenac, Flurbiprofen and Benzydamine in people with Pain and Quality of Life, run by Near East University, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Pericoronitis is a painful inflammatory condition which is well known for its negative impact on quality of life of those affected. The aim of this study was to test two hypotheses: (1) that topical application of Benzydamine is as effective as oral Diclofenac or Flurbiprofen in improving pain and quality of life of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Quality of Life
- What is being tested?
- Diclofenac, Flurbiprofen and Benzydamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 2 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Young adults aged 18 years or over
- Diagnosed with mild pericoronitis
- Having semi-impacted mandibular third molar
- Symptoms of pain and localized swelling
Who cannot join
- Smoking
- History of allergy to diclofenac, flurbiprofen, benzydamine or other NSAIDs
- Use of systemic antibiotics or analgesics within 3 days before admission
- The patients who had symptoms of severe pericoronitis such as fever higher than 101°F, dysphagia, trismus or facial swelling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Analgesics on Pain and Health-related Quality of Life of Patients With Pericoronitis in the Short-term Period: A Randomized, Double-blind, Clinical Trial
Pericoronitis is a painful inflammatory condition which is well known for its negative impact on quality of life of those affected. The aim of this study was to test two hypotheses: (1) that topical application of Benzydamine is as effective as oral Diclofenac or Flurbiprofen in improving pain and quality of life of patients with pericoronitis and (2) that there would be no difference between the effects of the two oral NSAIDs on pain and quality of life of patients with pericoronitis
- Conditions
- Pain, Quality of Life
- Being tested
- Diclofenac, Flurbiprofen, Benzydamine
- Keywords
- Pericoronitis, Analgesics, Non steroid anti-inflammatory drugs, Benzydamine, Quality of life
- Medical subject headings
- Pain, Pericoronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
All patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination.
FlurbiprofenDrug
All patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination.
BenzydamineDrug
All patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Experimental | Diclofenac group, which received diclofenac 50 mg capsules (Cataflam) and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor. Receives: Drug: Diclofenac |
| Flurbiprofen | Experimental | Flurbiprofen group, which received flurbiprofen 100 mg capsules and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor. Receives: Drug: Flurbiprofen |
| Benzydamine | Experimental | Benzydamine group, which received benzydamine 0.045 g, 30 mL oral sprays (Tantum Verde) and placebo capsules. Placebo capsules contained starch. Receives: Drug: Benzydamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health-Related Quality of Life Scores Evaluated
For the pre- treatment period, the Oral Health-Related Quality of Life scores change was evaluated in the 1st day after the clinical examination and before the treatment with the help of the 5-point Likert-type scale where each item was scored from 1 (no trouble) to 5 (lots of trouble).
Measured: Baseline
Oral Health-Related Quality of Life Scores Evaluated
For the post - treatment period, the Oral Health-Related Quality of Life scores change was evaluated with the help of the 5-point Likert-type scale where each item was scored from 1 (no trouble) to 5 (lots of trouble). Evaluated periods were 1, 2, 3, 5 and 7 days
Measured: one week after drug prescribed
Secondary outcomes (2)
Pain Scores Evaluated
For the pre-treatment period, the pain scores change was evaluated in the 1st day after the clinical examination and before the treatment with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Measured: Baseline
Pain Scores Evaluated
For the post-treatment period, the pain scores change was evaluated in the 1, 2, 3, 5 and 7days with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Measured: one week after drug prescribed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Nov 2017
- Primary completion3 Sep 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdullah alalwani, Near East University, Turkey
- Investigators
- Abdullah AlAlwani, DDS, Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745599
- Sponsor's protocol ID
- Near East Uni
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Analgesics on Pain and Health-related Quality of Life of Patients With Pericoronitis in the Short-term Period: A Randomized, Double-blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT03745599
- Acronym / sponsor ID
- Near East Uni
- Conditions
- Pain, Quality of Life
- Keywords
- Pericoronitis, Analgesics, Non steroid anti-inflammatory drugs, Benzydamine, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 19 Nov 2018 (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.
Pericoronitis is a painful inflammatory condition which is well known for its negative impact on quality of life of those affected. The aim of this study was to test two hypotheses: (1) that topical application of Benzydamine is as effective as oral Diclofenac or Flurbiprofen in improving pain and quality of life of patients with pericoronitis and (2) that there would be no difference between the effects of the two oral NSAIDs on pain and quality of life of patients with pericoronitis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Experimental | Drug: DiclofenacDiclofenac group, which received diclofenac 50 mg capsules (Cataflam) and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor. |
| Flurbiprofen | Experimental | Drug: FlurbiprofenFlurbiprofen group, which received flurbiprofen 100 mg capsules and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor. |
| Benzydamine | Experimental | Drug: BenzydamineBenzydamine group, which received benzydamine 0.045 g, 30 mL oral sprays (Tantum Verde) and placebo capsules. Placebo capsules contained starch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Young adults aged 18 years or over
- Diagnosed with mild pericoronitis
- Having semi-impacted mandibular third molar
- Symptoms of pain and localized swelling
Key exclusion criteria (4 listed)
- Smoking
- History of allergy to diclofenac, flurbiprofen, benzydamine or other NSAIDs
- Use of systemic antibiotics or analgesics within 3 days before admission
- The patients who had symptoms of severe pericoronitis such as fever higher than 101°F, dysphagia, trismus or facial swelling.
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 |
|---|---|---|
| DiclofenacAll patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination. | Drug | Diclofenac |
| FlurbiprofenAll patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination. | Drug | Flurbiprofen |
| BenzydamineAll patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination. | Drug | Benzydamine |
Primary outcome
Oral Health-Related Quality of Life Scores Evaluated
Time frame: Baseline
For the pre- treatment period, the Oral Health-Related Quality of Life scores change was evaluated in the 1st day after the clinical examination and before the treatment with the help of the 5-point Likert-type scale where each item was scored from 1 (no trouble) to 5 (lots of trouble).
Oral Health-Related Quality of Life Scores Evaluated
Time frame: one week after drug prescribed
For the post - treatment period, the Oral Health-Related Quality of Life scores change was evaluated with the help of the 5-point Likert-type scale where each item was scored from 1 (no trouble) to 5 (lots of trouble). Evaluated periods were 1, 2, 3, 5 and 7 days
2 secondary outcomes
Pain Scores Evaluated
Time frame: Baseline
Pain Scores Evaluated
Time frame: one week after drug prescribed
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 19 Nov 2018.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Abdullah AlAlwani, DDS principal investigator
Near East University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac, Flurbiprofen and Benzydamine in people with Pain and Quality of Life, run by Near East University, Turkey 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 4 inclusion and 4 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 19 Nov 2018. 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. 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?
Oral Health-Related Quality of Life Scores Evaluated (time frame: Baseline). The study lists 2 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 19 Nov 2018.