Unilateral Alveolar Cleft of MaxillaNCT07786259
Bone Marrow Aspirate Concentrate With Bovine Bone Graft for Unilateral Alveolar Cleft Reconstruction
A study testing BMAC-Enriched Bovine Bone Grafting and Bovine Bone Grafting in people with Unilateral Alveolar Cleft of Maxilla, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized clinical trial evaluated whether adding autologous bone marrow aspirate concentrate (BMAC) to a bovine-derived bone graft improves healing and bone regeneration in patients undergoing reconstruction of a unilateral alveolar cleft. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Unilateral Alveolar Cleft of Maxilla
- What is being tested?
- BMAC-Enriched Bovine Bone Grafting and Bovine Bone Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 16 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 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with unilateral alveolar clefts requiring repair.
- Patients with good oral hygiene and good general health.
- Patients free from any systemic disease that may affect normal bone healing.
- Patients aged 7 to 25 years.
- Absence of blood disorders that might cause complications following bone marrow aspiration.
Who cannot join
- Patients with bilateral alveolar clefts.
- Patients with local maxillary pathosis that may interfere with surgery.
- Immunocompromised patients.
- Patients with syndromes associated with alveolar cleft.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527
About this study
Official title: Evaluation of Bone Marrow Aspirate Concentrate Combined With Bovine Bone Graft for Unilateral Alveolar Cleft Repair (A Randomized Controlled Clinical Trial)
This randomized clinical trial evaluated whether adding autologous bone marrow aspirate concentrate (BMAC) to a bovine-derived bone graft improves healing and bone regeneration in patients undergoing reconstruction of a unilateral alveolar cleft. Sixteen participants were randomly assigned in a 1:1 ratio to receive either bovine bone graft combined with BMAC or bovine bone graft alone. Participants were followed for 6 months. Clinical assessments included postoperative pain, soft-tissue healing, fistula recurrence, and tooth eruption. Radiographic assessments included alveolar bone level, CT-derived graft radiodensity, and three-dimensional volumetric measurements of graft integration, resorption, and defect fill.
Read the detailed description
This prospective randomized controlled clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. The study investigated the clinical and radiographic effectiveness of bone marrow aspirate concentrate (BMAC) combined with a bovine-derived particulate bone graft for reconstruction of unilateral alveolar cleft defects. Eligible participants were randomly allocated in a 1:1 ratio to either the study group or the control group using a simple lottery method.
Participants in the study group received bovine-derived particulate bone graft combined with autologous BMAC, whereas participants in the control group received bovine-derived bone graft without BMAC. For the study group, BMAC was mixed with the bovine graft at a ratio of 1 mL of BMAC per 1 cc of graft approximately 10 minutes before implantation. The interval was used as a standardized procedural step to allow contact and wetting of the graft particles and was not considered a biologically validated incubation period.
Both groups underwent standardized alveolar cleft reconstruction and were followed for 6 months. Clinical evaluation included postoperative pain, soft-tissue healing, fistula recurrence, and tooth eruption. Radiographic evaluation included assessment of alveolar bone level using the Chelsea scale, CT-derived graft radiodensity, and three-dimensional volumetric analysis to assess graft integration, graft resorption, and effective defect fill.
- Conditions
- Unilateral Alveolar Cleft of Maxilla
- Being tested
- BMAC-Enriched Bovine Bone Grafting, Bovine Bone Grafting
- Keywords
- Alveolar Cleft, Bone Marrow Aspirate Concentrate, BMAC, Bovine Bone Graft, Secondary Alveolar Bone Grafting, Bone Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC-Enriched Bovine Bone GraftingProcedure or surgery
Autologous bone marrow aspirate concentrate (BMAC) was prepared from bone marrow aspirated from the anterior iliac crest and combined with bovine-derived particulate bone graft. BMAC was mixed with the graft at a ratio of 1 mL per 1 cc approximately 10 minutes before implantation into the alveolar cleft defect.
Bovine Bone GraftingProcedure or surgery
The unilateral alveolar cleft defect was reconstructed using bovine-derived particulate bone graft without the addition of BMAC.
| Study group | Role | What they receive |
|---|---|---|
| BMAC-Enriched Bovine Bone Graft | Experimental | Participants received a bovine-derived particulate bone graft combined with autologous bone marrow aspirate concentrate (BMAC) for reconstruction of the unilateral alveolar cleft. Receives: Procedure: BMAC-Enriched Bovine Bone Grafting |
| Bovine Bone Graft Alone | Active comparator | Participants received a bovine-derived particulate bone graft alone for reconstruction of the unilateral alveolar cleft. Receives: Procedure: Bovine Bone Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Take at 6 Months
Graft take was assessed using three-dimensional CT-derived volumetric analysis. It was calculated as the percentage of the grafted volume that remained integrated within the reconstructed alveolar cleft at the 6-month follow-up.
Measured: 6 months after surgery
Secondary outcomes (8)
Graft Resorption at 6 Months
Measured: 6 months after surgery
Effective Defect Fill at 6 Months
Measured: 6 months after surgery
Integrated Graft Volume at 6 Months
Measured: 6 months after surgery
CT-Derived Graft Radiodensity at 6 Months
Measured: 6 months after surgery
Chelsea Scale Bone Level Assessment at 6 Months
Measured: 6 months after surgery
Soft-Tissue Healing
Measured: 6 months after surgery
Nasal Regurgitation/Oronasal Fistula Recurrence
Measured: 6 months after surgery
Tooth Eruption
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Mar 2025
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unilateral Alveolar Cleft of MaxillaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Participants were randomized in a 1:1 ratio to receive either bovine-derived bone graft combined with BMAC or bovine-derived bone graft alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Ragab Mohamed Elbehwashy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786259
- Sponsor's protocol ID
- BMAC-AC-01
- Other IDs
- OS-2312
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported clinical and radiographic results may be shared upon reasonable request, subject to approval by the study investigators and applicable institutional and ethical requirements.
Publications
Kuhl S, Payer M, Kirmeier R, Wildburger A, Wegscheider W, Jakse N. The influence of bone marrow aspirates and concentrates on the early volume stability of maxillary sinus grafts with deproteinized bovine bone mineral - first results of a RCT. Clin Oral Implants Res. 2014 Feb;25(2):221-5. doi: 10.1111/clr.12101. Epub 2013 Jan 7.
PubMed 23294470Chahla J, Mannava S, Cinque ME, Geeslin AG, Codina D, LaPrade RF. Bone Marrow Aspirate Concentrate Harvesting and Processing Technique. Arthrosc Tech. 2017 Apr 10;6(2):e441-e445. doi: 10.1016/j.eats.2016.10.024. eCollection 2017 Apr.
PubMed 28580265Shabaan AA, Salahuddin A, Aboulmagd I, Ragab R, Salah KA, Rashid A, Ayad HM, El Aty Ahmed WA, Refahee SM. Alveolar cleft reconstruction using bone marrow aspirate concentrate and iliac cancellous bone: A 12-month randomized clinical study. Clin Oral Investig. 2023 Nov;27(11):6667-6675. doi: 10.1007/s00784-023-05276-9. Epub 2023 Oct 5.
PubMed 37794139
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Marrow Aspirate Concentrate Combined With Bovine Bone Graft for Unilateral Alveolar Cleft Repair (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07786259
- Acronym / sponsor ID
- BMAC-AC-01
- Conditions
- Unilateral Alveolar Cleft of Maxilla
- Keywords
- Alveolar Cleft, Bone Marrow Aspirate Concentrate, BMAC, Bovine Bone Graft, Secondary Alveolar Bone Grafting, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 25 Aug 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.
This randomized clinical trial evaluated whether adding autologous bone marrow aspirate concentrate (BMAC) to a bovine-derived bone graft improves healing and bone regeneration in patients undergoing reconstruction of a unilateral alveolar cleft. Sixteen participants were randomly assigned in a 1:1 ratio to receive either bovine bone graft combined with BMAC or bovine bone graft alone. Participants were followed for 6 months. Clinical assessments included postoperative pain, soft-tissue healing, fistula recurrence, and tooth eruption. Radiographic assessments included alveolar bone level, CT-derived graft radiodensity, and three-dimensional volumetric measurements of graft integration, resorption, and defect fill.
Detailed description
This prospective randomized controlled clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. The study investigated the clinical and radiographic effectiveness of bone marrow aspirate concentrate (BMAC) combined with a bovine-derived particulate bone graft for reconstruction of unilateral alveolar cleft defects. Eligible participants were randomly allocated in a 1:1 ratio to either the study group or the control group using a simple lottery method.
Participants in the study group received bovine-derived particulate bone graft combined with autologous BMAC, whereas participants in the control group received bovine-derived bone graft without BMAC. For the study group, BMAC was mixed with the bovine graft at a ratio of 1 mL of BMAC per 1 cc of graft approximately 10 minutes before implantation. The interval was used as a standardized procedural step to allow contact and wetting of the graft particles and was not considered a biologically validated incubation period.
Both groups underwent standardized alveolar cleft reconstruction and were followed for 6 months. Clinical evaluation included postoperative pain, soft-tissue healing, fistula recurrence, and tooth eruption. Radiographic evaluation included assessment of alveolar bone level using the Chelsea scale, CT-derived graft radiodensity, and three-dimensional volumetric analysis to assess graft integration, graft resorption, and effective defect fill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive either bovine-derived bone graft combined with BMAC or bovine-derived bone graft alone.
| Arm | Type | Receives |
|---|---|---|
| BMAC-Enriched Bovine Bone Graft | Experimental | Procedure: BMAC-Enriched Bovine Bone GraftingParticipants received a bovine-derived particulate bone graft combined with autologous bone marrow aspirate concentrate (BMAC) for reconstruction of the unilateral alveolar cleft. |
| Bovine Bone Graft Alone | Active comparator | Procedure: Bovine Bone GraftingParticipants received a bovine-derived particulate bone graft alone for reconstruction of the unilateral alveolar cleft. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with unilateral alveolar clefts requiring repair.
- Patients with good oral hygiene and good general health.
- Patients free from any systemic disease that may affect normal bone healing.
- Patients aged 7 to 25 years.
- Absence of blood disorders that might cause complications following bone marrow aspiration.
Key exclusion criteria (4 listed)
- Patients with bilateral alveolar clefts.
- Patients with local maxillary pathosis that may interfere with surgery.
- Immunocompromised patients.
- Patients with syndromes associated with alveolar cleft.
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-Enriched Bovine Bone GraftingAutologous bone marrow aspirate concentrate (BMAC) was prepared from bone marrow aspirated from the anterior iliac crest and combined with bovine-derived particulate bone graft. BMAC was mixed with the graft at a ratio of 1 mL per 1 cc approximately 10 minutes before implantation into the alveolar cleft defect. | Procedure or surgery | BMAC-Enriched Bovine Bone Graft |
| Bovine Bone GraftingThe unilateral alveolar cleft defect was reconstructed using bovine-derived particulate bone graft without the addition of BMAC. | Procedure or surgery | Bovine Bone Graft Alone |
Primary outcome
Graft Take at 6 Months
Time frame: 6 months after surgery
Graft take was assessed using three-dimensional CT-derived volumetric analysis. It was calculated as the percentage of the grafted volume that remained integrated within the reconstructed alveolar cleft at the 6-month follow-up.
8 secondary outcomes
Graft Resorption at 6 Months
Time frame: 6 months after surgery
Effective Defect Fill at 6 Months
Time frame: 6 months after surgery
Integrated Graft Volume at 6 Months
Time frame: 6 months after surgery
CT-Derived Graft Radiodensity at 6 Months
Time frame: 6 months after surgery
Chelsea Scale Bone Level Assessment at 6 Months
Time frame: 6 months after surgery
Soft-Tissue Healing
Time frame: 6 months after surgery
Nasal Regurgitation/Oronasal Fistula Recurrence
Time frame: 6 months after surgery
Tooth Eruption
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 23294470Kuhl S, Payer M, Kirmeier R, Wildburger A, Wegscheider W, Jakse N. The influence of bone marrow aspirates and concentrates on the early volume stability of maxillary sinus grafts with deproteinized bovine bone mineral - first results of a RCT. Clin Oral Implants Res. 2014 Feb;25(2):221-5. doi: 10.1111/clr.12101. Epub 2013 Jan 7.
- Background: PubMed 28580265Chahla J, Mannava S, Cinque ME, Geeslin AG, Codina D, LaPrade RF. Bone Marrow Aspirate Concentrate Harvesting and Processing Technique. Arthrosc Tech. 2017 Apr 10;6(2):e441-e445. doi: 10.1016/j.eats.2016.10.024. eCollection 2017 Apr.
- Background: PubMed 37794139Shabaan AA, Salahuddin A, Aboulmagd I, Ragab R, Salah KA, Rashid A, Ayad HM, El Aty Ahmed WA, Refahee SM. Alveolar cleft reconstruction using bone marrow aspirate concentrate and iliac cancellous bone: A 12-month randomized clinical study. Clin Oral Investig. 2023 Nov;27(11):6667-6675. doi: 10.1007/s00784-023-05276-9. Epub 2023 Oct 5.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported clinical and radiographic results may be shared upon reasonable request, subject to approval by the study investigators and applicable institutional and ethical requirements.
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.
The record lists no contact. Use the official record to reach the sponsor.
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-Enriched Bovine Bone Grafting and Bovine Bone Grafting in people with Unilateral Alveolar Cleft of Maxilla, run by Tanta 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 25 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Graft Take at 6 Months (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07786259, which also lists 3 linked publications.
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 25 Aug 2026.