Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

Assessment of Flurbiprofen Tablet and Spray For Postoperative Pain Control In Oral Soft Tissue Wounds: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Drug Effect; Drug Use; Oral Soft Tissue Conditions
• Intervention / Treatment: Drug: Flurbiprofen

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Van, Merkez, Turkey, 65090
      • Yuzuncu Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spray group; Spray group consisted of individuals who used flurbiprofen in spray form as a postoperative analgesic	Drug: Flurbiprofen; The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen; Other Names: Spray flurbiprofen vs Tablet flurbiprofen
Active Comparator: Tablet group; Tablet group consisted of individuals who used flurbiprofen in tablet form as a postoperative analgesic	Drug: Flurbiprofen; The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen; Other Names: Spray flurbiprofen vs Tablet flurbiprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain evaluation with Visual Analogue Scale (VAS) scores	The effect of analgesics used in the groups on the level of pain in VAS after soft tissue surgery was investigated.	One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue analgesic intake	It was investigated whether rescue analgesics were needed in the groups	One week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug intake amounts	Assessment of daily analgesic requirement in groups	One week

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Principal Investigator: Cennet N Eroglu, DDS,PhD, Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: flurpibrofen; oral soft tissue
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Flurbiprofen
• Other Study ID Numbers: 05/25102023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is published, the study information will be shared with the researchers who request it, taking into account the right to protect personal data
• IPD Sharing Time Frame: IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documents will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.
• IPD Sharing Access Criteria: IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documents will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No