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

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ClinicalTrials.gov Identifier: NCT03745599
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
abdullah alalwani, 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

Condition or disease Intervention/treatment Phase
Pain Quality of Life Drug: Diclofenac Drug: Flurbiprofen Drug: Benzydamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : September 3, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Experimental: Flurbiprofen
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
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.

Experimental: Benzydamine
Benzydamine group, which received benzydamine 0.045 g, 30 mL oral sprays (Tantum Verde) and placebo capsules. Placebo capsules contained starch.
Drug: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745599


Locations
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Turkey
Abdullah AlAlwani
Mersin, Turkey, 99010
Sponsors and Collaborators
Near East University, Turkey
Investigators
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Principal Investigator: Abdullah AlAlwani, DDS Near East University

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Responsible Party: abdullah alalwani, Research Assistant, Near East University, Turkey
ClinicalTrials.gov Identifier: NCT03745599     History of Changes
Other Study ID Numbers: Near East Uni
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by abdullah alalwani, Near East University, Turkey:
Pericoronitis
Analgesics
Non steroid anti-inflammatory drugs
Benzydamine
Quality of life

Additional relevant MeSH terms:
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Pericoronitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Analgesics
Diclofenac
Flurbiprofen
Benzydamine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action