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NCT05405738 Clinical Trial

Cleft Palate Technique and Maxillary Growth

Growth Clinical Trial

Official title:
Effect of 2 Flap Palatoplasty Versus Furlow With Buccinators Flap During Palatal Cleft Repair on the Maxillary Development Patterns in Comparison to Non-cleft Children at 5-6years of Age

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05405738
Other study ID # 2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2022
Est. completion date March 1, 2023

Study information
Verified date September 2023
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date March 1, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 6 Years
Eligibility Inclusion Criteria: - 5-6 years old childreen with previous treated complete cleft lip and palate, nonsyndromic. - lip and palate repair performed by one craniofacial surgeon Exclusion Criteria: - Patients with syndromic cleft lip. - Redu cases - Bilateral cleft lip - Patient older 6years or younger 5 years. - Associated Cardiac anomalies. - Any systemic condition

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 2 flap palatoplasty technique
cleft palate repair by 2 flap palatoplasty technique
Other:
• normal group
control normal group
Procedure:
• Furlow with buccinator technique
cleft palate repair by Furlow with buccinator technique

Locations
Country Name City State
Egypt Fayoum University Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary maxillar growth evaluation of the maxillary growth through Inter-canine width (ICW) measurement by mm through study completion, an average one week
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