Alveolar CleftNCT06585566
Alveolar Cleft Reconstruction With Cortical-Shells
A study testing Cortical-shell graft in people with Alveolar Cleft, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- Cortical-shell graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Oct 2024to 1 Oct 2025
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
- good oral hygiene and general good health
Who cannot join
- The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
- Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
- A history of previous failed alveolar cleft reconstruction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Amr Gibaly
Cairo, 62764
Amr Gibaly, 01113336634, amrgibaly@dent.bsu.edu.eg
- Recruiting
Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.
Cairo
About this study
Official title: Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)
The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.
The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.
- Conditions
- Alveolar Cleft
- Being tested
- Cortical-shell graft
- Keywords
- Bone graft, Cortical- shells, Radiographic Density, Horizontal bone gain, Vertical bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical-shell graftProcedure or surgery
Retromolar cortical shell graft technique for SABG
| Study group | Role | What they receive |
|---|---|---|
| Secondary alveolar bone grafting (SBAG) | Other | A SABG technique that utilizes retromolar cortical shells and the underlying cancellous particulates to formulate a three-dimensional alveolar cleft reconstruction. Receives: Procedure: Cortical-shell graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone width
The amplitude of radiographic horizontal bone width change
Measured: 6 months consolidation period
Secondary outcomes (2)
Vertical bone level
The amplitude of radiographic vertical bone change
Measured: 6 months consolidation period
Bone density
The radiographic bone density of the consolidated graft at the site of the reconstructed cleft
Measured: 6 months consolidation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start4 Oct 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- 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
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gibaly, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585566
- Sponsor's protocol ID
- 15
- Status last verified
- Jan 2025
- First submitted
- 3 Sep 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)
- ClinicalTrials.gov ID
- NCT06585566
- Acronym / sponsor ID
- 15
- Conditions
- Alveolar Cleft
- Keywords
- Bone graft, Cortical- shells, Radiographic Density, Horizontal bone gain, Vertical bone loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Sep 2024 (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.
The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.
The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secondary alveolar bone grafting (SBAG) | Other | Procedure: Cortical-shell graftA SABG technique that utilizes retromolar cortical shells and the underlying cancellous particulates to formulate a three-dimensional alveolar cleft reconstruction. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
- good oral hygiene and general good health
Key exclusion criteria (3 listed)
- The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
- Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
- A history of previous failed alveolar cleft reconstruction.
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 |
|---|---|---|
| Cortical-shell graftRetromolar cortical shell graft technique for SABG | Procedure or surgery | Secondary alveolar bone grafting (SBAG) |
Primary outcome
Horizontal bone width
Time frame: 6 months consolidation period
The amplitude of radiographic horizontal bone width change
2 secondary outcomes
Vertical bone level
Time frame: 6 months consolidation period
Bone density
Time frame: 6 months consolidation period
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 22 Jan 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortical-shell graft in people with Alveolar Cleft, run by Beni-Suef University at 2 sites in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Amr Hanafy Gibaly, PHD (01113336634, amrgibaly@dent.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone width (time frame: 6 months consolidation period). 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 22 Jan 2025.