Facial Artery Musculomucosal Flap and Bone Volume Gain in Alveolar Cleft Repair"

April 1, 2026 updated by: Sherif Abdel Monem Abdel Aziz, Cairo University

Evaluation of Facial Artery Musculomucosal Flap Technique On The Bone Volume Gain In Alveolar Cleft Repair.

Research question:

Is the usage of the facial artery musculomucosal flap (FAMM) technique effective on the bone volume in the repair of alveolar cleft?

Aim of the study:

To evaluate the application of the facial artery musculomucosal flap (FAMM) technique on the bone volume in the repair of alveolar cleft.

Trial design: clinical trial: one group, one arm containing (7) cases.

Statement of the problem:

The alveolar cleft has not obtained as much interest as labial or palatal clefts, and the management of this type of cleft remains controversial. There were multiple theories and preferred treatment methods regarding each step in alveolar cleft management according to grafting, the most appropriate age, the ideal material, and whether adjunctive procedures such as orthodontic expansion should be used before or after grafting.

Alveolar bone grafting (ABG) has been widely used to repair the alveolar bone defect in most cleft cases. The aim of ABG is the restoration of dental arch continuity and maxillary stability, closure of the oronasal fistulae (ONF), facilitation of subsequent orthodontic treatment, enhancement of nasal symmetry, establishment of better oral hygiene, and limitation of the growth disturbances.

FAMM flaps have been widely used for small- and medium-sized defects primarily of the oral cavity and other head and neck regions. Their clinical applications are diverse. They are mostly applied to reconstruct defects from tumor ablation, but other indications include repair of cleft palate, septal perforation, and osteoradionecrosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this research, we aim to evaluate the usage the FAMM flap in alveolar cleft cases to review functional results and radiographic results on bone volume and complications that will occur in the cases with alveolar bony defects.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The age of the patients will be 9-20 years.
  2. Patients with palatal expansion orthodontic treatment.

Exclusion Criteria:

  1. Active infections.
  2. Underlying diseases.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Application of FAMM flap on bone graft in alveolar cleft
Application of FAMM flap technique on bone graft in alveolar cleft
Procedure: Application of FAMM flap on bone graft in alveolar cleft
conventional approach for FAMM flap harvesting involves identifying the facial artery,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone volume. - Radiological evaluation using CBCT to measure bone height (H), bone width (W) and nasal floor (N).
Time Frame: an average of 1 year

Bone volume.

- Radiological evaluation using CBCT to measure bone height (H), bone width (W) and nasal floor (N).
an average of 1 year

Collaborators and Investigators

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

Sponsor

Cairo 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 (Estimated)

May 20, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

September 20, 2025

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sherifabdelazizelsaraf12345678

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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