Repair of Oronasal Fistula Using Interpositional Buccal Pad of Fat as a Free Graft in a Cleft Palate Patient

Not Applicable

• Conditions: Cleft Palate

• Registration Number: NCT06807450
• Lead Sponsor: Tanta University

Brief Summary

18 cleft palate patients had residual oronasal fistula included in this study divided randomly to two groups group I (control group): the fistula was repaired using two layers (oral and nasal layers) group II (study group): The fistula was repaired using two layers (oral and nasal layers ) with interpositional free buccal pad of fat graft between two layers

Detailed Description

18 cleft palate patients had residual oronasal fistula included in this study devided randomly to two groups group I (control group):the fistula was repaired using two layers nasal layer:closed by turn-in flaps, taken from around the margins of the fistula by making incision around margins of distance slightly larger than half of diameter of fistula bilaterally, then closed by inverted interrupted suture Vicry l 4/0.

oral layer:(Bardach two-flap palatoplasty) was used and raised on opposite sides of the cleft palate and brought together in the midline to create a continuous palate

group II (study group): The fistula was repaired using two layers (oral and nasal layers ) as group I with buccal pad of fat free graft was taken through veastibular incision at zygomatic buttress then blunt dissection to get buccal fat which was released from its pedicle and inserted between oral and nasal layers.

Study Timeline

• Study Start: 2024-04-23
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Status Verified: 2025-02
• Study First Posted: 2025-02-04
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-03-30
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• cleft palate patients with oro-nasal fistula fistula in hard palate

Exclusion Criteria

• syndromatic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
evaluation of wound healing	one month	five level; 1. very poor; 2. poor; 3. good; 4. very good; 5. excellent
recurrence of oro-nasal fistula	one -3 months	present or abscent

Secondary Outcome Measures

Name	Time	Method
postoperative pain	one month	using visual analogue scale (0-10) 0: no pain 10: the worest pain

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Egypt