Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

Phase 4

Completed

• Conditions: Drug Use; Oral Soft Tissue Conditions; Drug Effect
• Interventions: Drug: Flurbiprofen

• Registration Number: NCT06238154
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2023-10-26
• Primary Completion: 2024-01-12
• Study Completion: 2024-01-20
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tablet group	Flurbiprofen	Tablet group consisted of individuals who used flurbiprofen in tablet form as a postoperative analgesic
Spray group	Flurbiprofen	Spray group consisted of individuals who used flurbiprofen in spray form as a postoperative analgesic

Primary Outcome Measures

Name	Time	Method
Postoperative pain evaluation with Numeric Rating Scale scores	One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)	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.

Secondary Outcome Measures

Name	Time	Method
Rescue analgesic intake	One week	It was investigated whether rescue analgesics were needed in the groups

Trial Locations

Locations (1)

Yuzuncu Yil University; 🇹🇷 Van, Merkez, Turkey