Cleft Palate Technique and Maxillary Growth

September 26, 2023 updated by: Shaimaa Mohsen, Fayoum University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

5-6ys old child with treated cleft palate

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal group
Other: normal group
control normal group
2flap palatoplasty group
Procedure: 2 flap palatoplasty technique
cleft palate repair by 2 flap palatoplasty technique
Furlow with buccinator group
Procedure: Furlow with buccinator technique
cleft palate repair by Furlow with buccinator technique

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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