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Completed

NCT Number: NCT05166408

Fistiulation Rate Following Primary Cleft Repair≤

Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.

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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

9 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, 02, Egypt

About this study

Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients suffering from complete wide cleft palate more than 10 mm
  • Patients age from 9 to 18 months
  • Patients free from any systemic disease that might affect normal healing or the predictable outcome
  • Patients who will agree to the consent and stick to the follow up period

Exclusion criteria

  • Patients with systemic disease
  • Patients who might not stick to the follow up period
  • Patients with Pierre Robin syndrome
  • Patients with previous palatal repair

Treatment and study plan

Buccinator myomucosal flap

Procedure

Buccinator myomucosal flap for primary cleft palate palatoplasty

Bardach two flap palatoplasty

Procedure

Bardach two flap palatoplasty

Primary outcomes

  1. Fistiulation rate

    Time frame: 6 months

    The rate of palatal fistula formation following primary cleft palate repair ( number of patients complicated with palatal fistula compared to the full patients number)

Secondary outcomes

  1. Palatal length & risk of VPI

    Time frame: 6 months

    The length of soft palate after surgical repair in correlation with the risk of future velopharyngeal insufficiency ( linear scale)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Novel Technique Predicting Velopharyngeal Insufficiency Risk in Newborns Following Primary Cleft Repair. A Randomised Clinical Trial Comparing Buccinator Flap and Bardach; Two-flap Palatoplasty.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2021
Registry last updated
Dec 22, 2021

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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