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
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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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-10-11
2025-11-19
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
20 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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mona samy sheta
principle 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
Countries
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Other Identifiers
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202014
Identifier Type: -
Identifier Source: org_study_id