Clinical trial NCT06238154: Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds
Official title: Assessment of Flurbiprofen Tablet and Spray For Postoperative Pain Control In Oral Soft Tissue Wounds: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Soft Tissue Conditions
Drug Effect
Drug Use
Keywords: flurpibrofen
oral soft tissue
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain evaluation with Numeric Rating Scale scores
timeFrame: One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)
Secondary outcomes:
measure: Rescue analgesic intake
timeFrame: One week
Other outcomes:
measure: Drug intake amounts
timeFrame: One week
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
state: Merkez
Study officials:
affiliation: Yuzuncu Yıl University
name: Cennet N Eroglu, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References: