Fistiulation Rate Following Primary Cleft Repair≤

NCT05166408 | Completed

• 1 other identifier: Primary palatoplasty fistula
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Palate

Keywords

Cleft palate; Primary repair; Buccinator flap; Palatal fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Palatal length & risk of VPI

  6 months

Study Arms (2)

Buccinator myomucosal flap for primary cleft repair

OTHER

Study group

Procedure: Buccinator myomucosal flap

Bardach two flap palatoplasty for primary cleft repair

OTHER

Control group

Procedure: Bardach two flap palatoplasty

Interventions

Buccinator myomucosal flap PROCEDURE

Buccinator myomucosal flap for primary cleft palate palatoplasty

Buccinator myomucosal flap for primary cleft repair

Bardach two flap palatoplasty PROCEDURE

Bardach two flap palatoplasty

Bardach two flap palatoplasty for primary cleft repair

Eligibility Criteria

• Age: 9 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

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

Study Officials

• Wael Abdelsamee

  Research organizer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 22, 2021
• Study Start: September 24, 2019
• Primary Completion: January 1, 2021
• Study Completion: February 5, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

EG (1)