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Completed

NCT Number: NCT06807450

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

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

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Key information

Conditions

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

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • syndromatic patients

Treatment and study plan

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

Other names: repair of oro-nasal fistula in cleft palate patients

Primary outcomes

  1. evaluation of wound healing

    Time frame: one month

    five level

    • very poor
    • poor
    • good
    • very good
    • excellent

  2. recurrence of oro-nasal fistula

    Time frame: one -3 months

    present or abscent

Secondary outcomes

  1. postoperative pain

    Time frame: one month

    using visual analogue scale (0-10) 0: no pain 10: the worest pain

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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