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

Near East University, Turkey

Status and phase: Completed; Phase 4

Conditions: Quality of Life; Pain

Treatments: Drug: Flurbiprofen; Drug: Benzydamine; Drug: Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT03745599

Near East Uni

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Diclofenac

Experimental group

Description:

Diclofenac group, which received diclofenac 50 mg capsules (Cataflam) and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor.

Treatment:

Drug: Diclofenac

Flurbiprofen

Experimental group

Description:

Flurbiprofen group, which received flurbiprofen 100 mg capsules and placebo sprays. Placebo sprays have consisted of a normal saline solution and peppermint flavor.

Treatment:

Drug: Flurbiprofen

Benzydamine

Experimental group

Description:

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

Treatment:

Drug: Benzydamine