Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

Yuzuncu Yil University40 enrolled

Overview

The amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects on postoperative pain in primarily closed soft tissue wounds in the oral region.

In line with the number of patients obtained after sample size calculation, the study was completed on 40 patients who met the inclusion criteria. Patients were healthy, volunteer individuals who required excision of the epulis fissuratum or frenulum with the indication of preprosthetic surgery. 2 groups were formed by simple randomization with 20 patients in the tablet group and 20 patients in the spray group. After the surgical procedure, tablet and spray flurbiprofen were prescribed according to the groups. Apart from these, paracetamol, chlorhexidine gluconate + benzidamine hydrochloride mouthwash were prescribed to all patients as rescue analgesics. The tissue fragments removed from the patients who underwent epulis excision were sent for histopathologic evaluation and confirmed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Oral Soft Tissue Conditions Drug Effect Drug Use

Interventions

FlurbiprofenDRUG

The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provided that those using removable prosthesis had discontinued using the prosthesis 1 month ago (in order to minimize the lesion to be excised), healthy or ASA Class I patients between 40 and 65 years of age, who had the indication of pre-prosthetic surgery due to excision of epulis fissuratum and frenulum Exclusion Criteria: * Pregnancy, lactation, and taking contraceptive pills; being allergic to the drug or other NSAIDs to be used in the study; had used steroids or analgesic drugs for any reason for the last 1 month; using psychiatric drugs; those with incomplete data and refused to sign the consent form; those who were extremely afraid and had a gag reflex; those with any gastrointesinal problems; smoking, ASA-2 and ASA-3 patients and those who smoked.

Locations (1)

Yuzuncu Yil University

Van, Merkez, Turkey (Türkiye)

Outcomes

Primary Outcomes

Postoperative pain evaluation with Numeric Rating Scale scores

The effect of analgesics used in the groups on the level of pain in Numeric Rating Scale (The pain intensity was assessed on a 0-10 ranking scale with 0 representing "no pain" and 10 "most severe pain" ) after soft tissue surgery was investigated.

Time frame: One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)

Secondary Outcomes

Rescue analgesic intake

It was investigated whether rescue analgesics were needed in the groups

Time frame: One week

Data from ClinicalTrials.gov

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