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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05166408
Other study ID # Primary palatoplasty fistula
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2019
Est. completion date February 5, 2021

Study information

Verified date December 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date February 5, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Months to 18 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Buccinator myomucosal flap
Buccinator myomucosal flap for primary cleft palate palatoplasty
Bardach two flap palatoplasty
Bardach two flap palatoplasty

Locations

Country Name City State
Egypt Faculty of Dentistry, Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 6 months
Secondary Palatal length & risk of VPI The length of soft palate after surgical repair in correlation with the risk of future velopharyngeal insufficiency ( linear scale) 6 months
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