Comparison of Pain Between Buccal Fat Pad and Buccal Advancement Flap

NCT07782151 | Completed

• 1 other identifier: SMDC/SMRC/246-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial compares postoperative pain following surgical closure using a buccal fat pad flap versus a buccal advancement flap. The study aims to determine whether there is a difference in postoperative pain between the two surgical techniques in patients undergoing treatment for oroantral fistula. Pain will be assessed after surgery using the study's predefined pain assessment method.

Conditions

Oroantral Fistula

Keywords

Oroantral fistula; Buccal Fat pad; Buccal advancement flap; Oroantral fistula closure; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain measured by Visual Analogue Scale (VAS)

  Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 24 hours and 7 days after surgery. The VAS ranges from 0 to 100 mm, where 0 mm represents no pain and 100 mm represents the worst pain imaginable. Higher scores indicate greater pain and therefore a worse outcome. Pain scores will be compared between patients treated with buccal fat pad flap and buccal advancement flap.

  24 hours and 7 days post-operation

Study Arms (2)

Buccal fat pad

EXPERIMENTAL

Participants assigned to this arm will undergo surgical closure using a buccal fat pad flap. Postoperative pain will be assessed and compared with the buccal advancement flap group.

Procedure: Buccal fat pad flap

Buccal advancement flap

ACTIVE COMPARATOR

Participants assigned to this arm will undergo surgical closure using a buccal advancement flap. Postoperative pain will be assessed and compared with the buccal fat pad group.

Procedure: Buccal advancement flap

Interventions

Buccal fat pad flap PROCEDURE

Surgical closure using a buccal fat pad flap. Postoperative pain will be assessed following the procedure.

Buccal fat pad

Buccal advancement flap PROCEDURE

Surgical closure using a buccal advancement flap. Postoperative pain will be assessed following the procedure.

Buccal advancement flap

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with clinically diagnosed oroantral fistula (OAF).
• Age 30 to 60 years.
• Both male and female patients who are Pakistani nationals.
• Patients willing to continue with the study.

You may not qualify if:

• Patients with diabetes mellitus.
• Patients with oral cancer.
• Patients who have received head and neck radiotherapy.

Sponsors & Collaborators

• Asma Noureen: lead

Study Sites (1)

Sharif Medical City Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Oroantral Fistula; Pain, Postoperative

Condition Hierarchy (Ancestors)

Oral Fistula; Mouth Diseases; Stomatognathic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Resident Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 24, 2026
• Study Start: June 9, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)