Alveolar Cleft GraftingNCT04414423
Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting
A study testing bone marrow concentrate alveolar cleft grafting and Autogenous alveolar grafting in people with Alveolar Cleft Grafting, run by Fayoum University at 2 sites in Egypt.
Trial summary
The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Alveolar Cleft Grafting
- What is being tested?
- bone marrow concentrate alveolar cleft grafting and Autogenous alveolar grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2020to 1 Dec 2021
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients suffering from maxillary alveolar cleft
- Patient with Primary, complete cleft lip
Who cannot join
- Syndromic cases will be excluded
- Previous operated cases
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry
Al Fayyum, 63514
Faculty of Dentistry
Cairo, 21523
About this study
Official title: Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation
The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.
Read the detailed description
Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study.
The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B).
Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.
- Conditions
- Alveolar Cleft Grafting
- Being tested
- bone marrow concentrate alveolar cleft grafting, Autogenous alveolar grafting
- Keywords
- bone marrow concentrate, alveolar cleft, CBCT, Bone density, bone volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow concentrate alveolar cleft graftingProcedure or surgery
patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
Autogenous alveolar graftingProcedure or surgery
patients will undergo surgery to repair alveolar cleft with autogenous bone graft
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow concentrate | Experimental | Bone marrow concentrate combined with Autogenous bone graft Receives: Procedure: bone marrow concentrate alveolar cleft grafting |
| autogenous bone graft | Active comparator | grafting with autogenous bone graft Receives: Procedure: Autogenous alveolar grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone volume
V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices
Measured: six months postoperative
Secondary outcomes (2)
bone density
the average bone density will be measured from the CBCT
Measured: six months postoperative
bone formation ratio
BF% = (formed volume/alveolar defect) × 100%.
Measured: six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Nov 2020
- Primary completion20 Nov 2021
- Study completion1 Dec 2021
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 Alveolar Cleft GraftingStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Ahmed shabaan, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414423
- Sponsor's protocol ID
- BMC AlvCleft
- Status last verified
- Dec 2021
- First submitted
- 25 May 2020
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinheiro FHSL, Drummond RJ, Frota CM, Bartzela TN, Dos Santos PB. Comparison of early and conventional autogenous secondary alveolar bone graft in children with cleft lip and palate: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):385-397. doi: 10.1111/ocr.12394. Epub 2020 Jun 28.
PubMed 32446283Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.
PubMed 31034242Shabaan 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 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation
- ClinicalTrials.gov ID
- NCT04414423
- Acronym / sponsor ID
- BMC AlvCleft
- Conditions
- Alveolar Cleft Grafting
- Keywords
- bone marrow concentrate, alveolar cleft, CBCT, Bone density, bone volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 4 Jun 2020 (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 aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.
Detailed description
Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study.
The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B).
Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
| Arm | Type | Receives |
|---|---|---|
| Bone marrow concentrate | Experimental | Procedure: bone marrow concentrate alveolar cleft graftingBone marrow concentrate combined with Autogenous bone graft |
| autogenous bone graft | Active comparator | Procedure: Autogenous alveolar graftinggrafting with autogenous bone graft |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients suffering from maxillary alveolar cleft
- Patient with Primary, complete cleft lip
Key exclusion criteria (2 listed)
- Syndromic cases will be excluded
- Previous operated cases
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 |
|---|---|---|
| bone marrow concentrate alveolar cleft graftingpatients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate | Procedure or surgery | Bone marrow concentrate |
| Autogenous alveolar graftingpatients will undergo surgery to repair alveolar cleft with autogenous bone graft | Procedure or surgery | autogenous bone graft |
Primary outcome
bone volume
Time frame: six months postoperative
V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices
2 secondary outcomes
bone density
Time frame: six months postoperative
bone formation ratio
Time frame: six months postoperative
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 7 Dec 2021.
- Background: PubMed 32446283Pinheiro FHSL, Drummond RJ, Frota CM, Bartzela TN, Dos Santos PB. Comparison of early and conventional autogenous secondary alveolar bone graft in children with cleft lip and palate: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):385-397. doi: 10.1111/ocr.12394. Epub 2020 Jun 28.
- Background: PubMed 31034242Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.
- Derived from this study: 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: 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone marrow concentrate alveolar cleft grafting and Autogenous alveolar grafting in people with Alveolar Cleft Grafting, run by Fayoum 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 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: finished, as of the sponsor's last update on 7 Dec 2021. 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?
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?
bone volume (time frame: six months postoperative). 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 NCT04414423, 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 7 Dec 2021.