Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

Yuzuncu Yıl University

Status and phase

Completed

Phase 4

Conditions

Oral Soft Tissue Conditions

Drug Effect

Drug Use

Treatments

Drug: Flurbiprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT06238154

05/25102023

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.