Alveolar Cleft GraftingBMACNCT06356870
Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone.
A study testing BMAC MIXED WITH ALLOGRAFT and Cancellous bone from anterior iliac crest in people with Alveolar Cleft Grafting, run by Cairo University at 1 site in Egypt.
Trial summary
radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Alveolar Cleft Grafting
- What is being tested?
- BMAC MIXED WITH ALLOGRAFT and Cancellous bone from anterior iliac crest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- alveolar cleft patients at the mixed dentition phase
Who cannot join
- patients with previous alveolar grafting intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alveolar Cleft Reconstruction Using BMAC and Allograft vs Iliac Cancellous Bone: A Randomized Clinical Trial.
radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting
Read the detailed description
In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting
In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.
- Conditions
- Alveolar Cleft Grafting
- Being tested
- BMAC MIXED WITH ALLOGRAFT, Cancellous bone from anterior iliac crest
- Keywords
- BMAC, alveolar cleft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC MIXED WITH ALLOGRAFTProcedure or surgery
Study group
Cancellous bone from anterior iliac crestProcedure or surgery
Control group
| Study group | Role | What they receive |
|---|---|---|
| Allograft mixed with BMAC | Experimental | Allograft mixed with BMAC used for alveolar cleft grafting Receives: Procedure: BMAC MIXED WITH ALLOGRAFT |
| Anterior iliac crest cancellous bone only | Active comparator | Anterior iliac crest cancellous bone only used for alveolar cleft grafting Receives: Procedure: Cancellous bone from anterior iliac crest |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone density
Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)
Measured: 6 months
Secondary outcomes (2)
Bone gain
Assessment of bone gain at the grafting site from a CT scan in millimeters
Measured: 6 months
Postoperative donor site morbidity
Assessment of donor site morbidity with a questionnaire (VAS Score)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Cleft GraftingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Moustafa Ismail Abdelmaksoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356870
- Sponsor's protocol ID
- BUE
- Acronym
- BMAC
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Cleft Reconstruction Using BMAC and Allograft vs Iliac Cancellous Bone: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06356870
- Acronym / sponsor ID
- BMAC / BUE
- Conditions
- Alveolar Cleft Grafting
- Keywords
- BMAC, alveolar cleft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Apr 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.
radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting
Detailed description
In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting
In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Allograft mixed with BMAC | Experimental | Procedure: BMAC MIXED WITH ALLOGRAFTAllograft mixed with BMAC used for alveolar cleft grafting |
| Anterior iliac crest cancellous bone only | Active comparator | Procedure: Cancellous bone from anterior iliac crestAnterior iliac crest cancellous bone only used for alveolar cleft grafting |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- alveolar cleft patients at the mixed dentition phase
Key exclusion criteria (1 listed)
- patients with previous alveolar grafting intervention
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 |
|---|---|---|
| BMAC MIXED WITH ALLOGRAFTStudy group | Procedure or surgery | Allograft mixed with BMAC |
| Cancellous bone from anterior iliac crestControl group | Procedure or surgery | Anterior iliac crest cancellous bone only |
Primary outcome
bone density
Time frame: 6 months
Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)
2 secondary outcomes
Bone gain
Time frame: 6 months
Postoperative donor site morbidity
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMAC MIXED WITH ALLOGRAFT and Cancellous bone from anterior iliac crest in people with Alveolar Cleft Grafting, run by Cairo University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Abdelmaksoud (01092490609, ahmedmostafa10@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone density (time frame: 6 months). 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 10 Apr 2024.