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Fistiulation Rate Following Primary Cleft Repair≤

Primary Purpose

Cleft Palate

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Buccinator myomucosal flap

Bardach two flap palatoplasty

About this trial

This is an interventional treatment trial for Cleft Palate focused on measuring Cleft palate, Primary repair, Buccinator flap, Palatal fistula

Eligibility Criteria

9 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Buccinator myomucosal flap for primary cleft repair

Bardach two flap palatoplasty for primary cleft repair

Arm Description

Study group

Control group

Outcomes

Primary Outcome Measures

Fistiulation rate

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 Outcome Measures

Palatal length & risk of VPI

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

Full Information

NCT ID

NCT05166408

First Posted

December 5, 2021

Last Updated

December 19, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05166408

Brief Title

Fistiulation Rate Following Primary Cleft Repair≤

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

September 24, 2019 (Actual)

Primary Completion Date

January 1, 2021 (Actual)

Study Completion Date

February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cleft Palate

Keywords

Cleft palate, Primary repair, Buccinator flap, Palatal fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buccinator myomucosal flap for primary cleft repair

Arm Type

Other

Arm Description

Study group

Arm Title

Bardach two flap palatoplasty for primary cleft repair

Arm Type

Other

Arm Description

Control group

Intervention Type

Procedure

Intervention Name(s)

Buccinator myomucosal flap

Intervention Description

Buccinator myomucosal flap for primary cleft palate palatoplasty

Intervention Type

Procedure

Intervention Name(s)

Bardach two flap palatoplasty

Intervention Description

Bardach two flap palatoplasty

Primary Outcome Measure Information:

Title

Fistiulation rate

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Palatal length & risk of VPI

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Months

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wael Abdelsamee

Organizational Affiliation

Research organizer

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Dentistry, Cairo University

City

Cairo

ZIP/Postal Code

Country

Egypt

12. IPD Sharing Statement

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Fistiulation Rate Following Primary Cleft Repair≤

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