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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03745599
Enrollment
60
Registered
2018-11-19
Start date
2017-11-01
Completion date
2018-11-02
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Quality of Life

Keywords

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

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

Interventions

DRUGDiclofenac

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.

DRUGFlurbiprofen

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.

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.

Sponsors

Near East University, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oral Health-Related Quality of Life Scores EvaluatedBaselineFor 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).

Secondary

MeasureTime frameDescription
Pain Scores EvaluatedBaselineFor 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).

Other

MeasureTime frameDescription
Oral Health Impact Profile (OHIP-14) Scores EvaluatedBaseline and one week after drug prescribedBefore 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026