Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life

Study Overview
=================
Brief 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 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

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

Conditions
-----------------
Pain, Quality of Life

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Flurbiprofen
* Drug: Benzydamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young adults aged 18 years or over Diagnosed with mild pericoronitis Having semi-impacted mandibular third molar Symptoms of pain and localized swelling Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac<br>Diclofenac group, which received diclofenac 50 mg capsules (Cataflam) and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor. | Drug: Diclofenac<br>* 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.<br>|
| Experimental: Flurbiprofen<br>Flurbiprofen group, which received flurbiprofen 100 mg capsules and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor. | Drug: Flurbiprofen<br>* 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.<br>|
| Experimental: Benzydamine<br>Benzydamine group, which received benzydamine 0.045 g, 30 mL oral sprays (Tantum Verde) and placebo capsules. Placebo capsules contained starch. | Drug: Benzydamine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | one week after drug prescribed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | one week after drug prescribed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pericoronitis, Analgesics, Non steroid anti-inflammatory drugs, Benzydamine, Quality of life