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

NCT03745599 | Completed Phase 4

• 1 other identifier: Near East Uni
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Quality of Life

Keywords

Pericoronitis; Analgesics; Non steroid anti-inflammatory drugs; Benzydamine; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain Scores Evaluated

  Baseline

• Pain Scores Evaluated

  one week after drug prescribed

Other Outcomes (1)

• Oral Health Impact Profile (OHIP-14) Scores Evaluated

  Baseline and one week after drug prescribed

Study Arms (3)

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.

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.

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.

Drug: Benzydamine

Interventions

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.

Diclofenac

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.

Flurbiprofen

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.

Benzydamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young adults aged 18 years or over
• Diagnosed with mild pericoronitis
• Having semi-impacted mandibular third molar
• Symptoms of pain and localized swelling

You may not qualify if:

• 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.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Abdullah AlAlwani

Mersin, 99010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Pericoronitis

Interventions

Diclofenac; Flurbiprofen; Benzydamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propionates; Acids, Acyclic; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Abdullah AlAlwani, DDS

  Near East University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 19, 2018
• Study Start: November 1, 2017
• Primary Completion: September 3, 2018
• Study Completion: November 2, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

TU (1)