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

Phase 4

Completed

• Conditions: Quality of Life; Pain
• Interventions: Drug: Diclofenac; Drug: Flurbiprofen; Drug: Benzydamine

• Registration Number: NCT03745599
• Lead Sponsor: Near East University, Turkey

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-09-03
• Status Verified: 2018-11
• Study Completion: 2018-11-02
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-16
• Last Update Submitted: 2018-11-16
• Study First Posted: 2018-11-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac	Diclofenac	Diclofenac group, which received diclofenac 50 mg capsules (Cataflam) and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor.
Flurbiprofen	Flurbiprofen	Flurbiprofen group, which received flurbiprofen 100 mg capsules and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor.
Benzydamine	Benzydamine	Benzydamine group, which received benzydamine 0.045 g, 30 mL oral sprays (Tantum Verde) and placebo capsules. Placebo capsules contained starch.

Primary Outcome Measures

Name	Time	Method
Oral Health-Related Quality of Life Scores Evaluated	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

Secondary Outcome Measures

Name	Time	Method
Pain Scores Evaluated	one week after drug prescribed	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).

Trial Locations

Locations (1)

Abdullah AlAlwani; 🇹🇷 Mersin, Turkey