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

NCT06807450 | Completed

• 1 other identifier: 202014
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

36 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

Conditions

Cleft Palate

Keywords

oro-nasal fistula; cleft palate; buccal pad of fat free graft

Outcome Measures

Primary Outcomes (2)

• evaluation of wound healing

  five level 1. very poor 2. poor 3. good 4. very good 5. excellent

  one month

• recurrence of oro-nasal fistula

  present or abscent

  one -3 months

Secondary Outcomes (1)

• postoperative pain

  one month

Study Arms (2)

repair of oro-nasal fistula using two layers

EXPERIMENTAL

the fistula will be closed using two layers nasal layer by turning over the fistula margin and closure with 4/0 vicryl oral layer using two flap palatoplasty with relaxing incision around the alveolar margin and approximate at the midline using 4/0 vicryl

Procedure: closure of oro-nasal fistula in cleft palate patients

repair of oro-nasal fistula using two layers with interpositional buccal pad of fat free graft

EXPERIMENTAL

the fistula will be closed using two layers nasal layer by turning over the fistula margin and closure with 4/0 vicryl oral layer using two flap palatoplasty with relaxing incision around the alveolar margin and approximate at the midline using 4/0 vicryl then a free graft of buccal pad of fat will be obtained and inserted between the two layers

Procedure: closure of oro-nasal fistula in cleft palate patients

Interventions

closure of oro-nasal fistula in cleft palate patients PROCEDURE

group I : Oro-nasal fistula will be closed in two layers, nasal layer by closing the fistula margin and turning over of flap and oral layer will be closed using two flap palatoplasty group II; the same procedure with insertion of free graft of buccal pad of fat between oral and nasal layers

Also known as: repair of oro-nasal fistula in cleft palate patients

repair of oro-nasal fistula using two layers; repair of oro-nasal fistula using two layers with interpositional buccal pad of fat free graft

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• syndromatic patients

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• mona s sheta, lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: October 11, 2023
• Primary Completion: March 30, 2025
• Study Completion: November 19, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

EG (1)