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Fistiulation Rate Following Primary Cleft Repair≤

NCT ID: NCT05166408

Last Updated: 2021-12-22

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2021-02-05

Brief Summary

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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

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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.

Conditions

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Cleft Palate

Keywords

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Cleft palate Primary repair Buccinator flap Palatal fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Buccinator myomucosal flap for primary cleft repair

Study group

Group Type OTHER

Buccinator myomucosal flap

Intervention Type PROCEDURE

Buccinator myomucosal flap for primary cleft palate palatoplasty

Bardach two flap palatoplasty for primary cleft repair

Control group

Group Type OTHER

Bardach two flap palatoplasty

Intervention Type PROCEDURE

Bardach two flap palatoplasty

Interventions

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Buccinator myomucosal flap

Buccinator myomucosal flap for primary cleft palate palatoplasty

Intervention Type PROCEDURE

Bardach two flap palatoplasty

Bardach two flap palatoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with systemic disease
2. Patients who might not stick to the follow up period
3. Patients with Pierre Robin syndrome
4. Patients with previous palatal repair
Minimum Eligible Age

9 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Walaa Kadry

Lecturer of oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wael Abdelsamee

Role: STUDY_CHAIR

Research organizer

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Primary palatoplasty fistula

Identifier Type: -

Identifier Source: org_study_id