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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745599
• Other study ID #: Near East Uni
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: November 2, 2018

Study information

• Verified date: November 2018
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pericoronitis
• Quality of Life

Intervention

Drug:
• Diclofenac
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.
• Flurbiprofen
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.
• Benzydamine
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.

Locations

Country	Name	City	State
Turkey	Abdullah AlAlwani	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral Health Impact Profile (OHIP-14) Scores Evaluated	Before and after the treatment period, the Oral Health Impact Profile scores change was evaluated in the 1st day after the clinical examination and before the treatment (baseline), and after 7 days with the help of the 5-point scale where each item was scored from "never" = 0, "hardly ever" = 1, "occasionally" = 2, "fairly often" = 3, "very often = 4"	Baseline and one week after drug prescribed
Primary	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
Primary	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	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
Secondary	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