FAMM Flap Functional & Radiographic ReviewNCT07512531
Facial Artery Musculomucosal Flap and Bone Volume Gain in Alveolar Cleft Repair"
A study testing Application of FAMM flap on bone graft in alveolar cleft in people with FAMM Flap Functional & Radiographic Review, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 20 years
- Conditions the study is for
- FAMM Flap Functional & Radiographic Review
- What is being tested?
- Application of FAMM flap on bone graft in alveolar cleft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The age of the patients will be 9-20 years.
- Patients with palatal expansion orthodontic treatment.
Who cannot join
- Active infections.
- Underlying diseases.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Being tested
- Application of FAMM flap on bone graft in alveolar cleft
- Keywords
- Alveolar cleft, bone grafting, FAMM, bone gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of FAMM flap on bone graft in alveolar cleftProcedure or surgery
conventional approach for FAMM flap harvesting involves identifying the facial artery,
| Study group | Role | What they receive |
|---|---|---|
| Application of FAMM flap on bone graft in alveolar cleft | Other | Application of FAMM flap technique on bone graft in alveolar cleft Receives: Procedure: Application of FAMM flap on bone graft in alveolar cleft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume. - Radiological evaluation using CBCT to measure bone height (H), bone width (W) and nasal floor (N).
Bone volume.
- Radiological evaluation using CBCT to measure bone height (H), bone width (W) and nasal floor (N).
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start20 May 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FAMM Flap Functional & Radiographic ReviewStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdel Monem Abdel Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512531
- Sponsor's protocol ID
- Sherifabdelazizelsaraf12345678
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Facial Artery Musculomucosal Flap Technique On The Bone Volume Gain In Alveolar Cleft Repair.
- ClinicalTrials.gov ID
- NCT07512531
- Acronym / sponsor ID
- Sherifabdelazizelsaraf12345678
- Keywords
- Alveolar cleft, bone grafting, FAMM, bone gain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of FAMM flap on bone graft in alveolar cleft | Other | Procedure: Application of FAMM flap on bone graft in alveolar cleftApplication of FAMM flap technique on bone graft in alveolar cleft |
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The age of the patients will be 9-20 years.
- Patients with palatal expansion orthodontic treatment.
Key exclusion criteria (2 listed)
- Active infections.
- Underlying diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of FAMM flap on bone graft in alveolar cleftconventional approach for FAMM flap harvesting involves identifying the facial artery, | Procedure or surgery | Application of FAMM flap on bone graft in alveolar cleft |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Application of FAMM flap on bone graft in alveolar cleft in people with FAMM Flap Functional & Radiographic Review, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.