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

NCT ID: NCT06807450

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-11

Study Completion Date

2025-11-19

Brief Summary

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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

Detailed Description

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36 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.

Conditions

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Cleft Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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repair of oro-nasal fistula using two layers

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

Group Type EXPERIMENTAL

closure of oro-nasal fistula in cleft palate patients

Intervention Type 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

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

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

Group Type EXPERIMENTAL

closure of oro-nasal fistula in cleft palate patients

Intervention Type 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

Interventions

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closure of oro-nasal fistula in cleft palate patients

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

Intervention Type PROCEDURE

Other Intervention Names

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repair of oro-nasal fistula in cleft palate patients

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* syndromatic patients
Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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mona samy sheta

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mona s sheta, lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Faculty of Dentistry, Tanta University

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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202014

Identifier Type: -

Identifier Source: org_study_id