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NCT Number: NCT07512531

Facial Artery Musculomucosal Flap and 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.

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Key information

Age range

9 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active infections.
  • Underlying diseases.

Treatment and study plan

Application of FAMM flap on bone graft in alveolar cleft

Procedure

conventional approach for FAMM flap harvesting involves identifying the facial artery,

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.