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NCT Number: NCT03745599

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

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

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Key information

Conditions

Pain Gingival Diseases Mouth Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pericoronitis Periodontal Diseases Quality of Life Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Abdullah AlAlwani

Mersin, 99010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. Pain Scores Evaluated

    Time frame: Baseline

    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).

  2. Pain Scores Evaluated

    Time frame: 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).

Other outcomes

  1. Oral Health Impact Profile (OHIP-14) Scores Evaluated

    Time frame: Baseline and one week after drug prescribed

    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"

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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