Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting
NCT ID: NCT04414423
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2020-11-01
2021-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bone marrow concentrate
Bone marrow concentrate combined with Autogenous bone graft
bone marrow concentrate alveolar cleft grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
autogenous bone graft
grafting with autogenous bone graft
Autogenous alveolar grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft
Interventions
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bone marrow concentrate alveolar cleft grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
Autogenous alveolar grafting
patients will undergo surgery to repair alveolar cleft with autogenous bone graft
Eligibility Criteria
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Inclusion Criteria
* Patient with Primary, complete cleft lip
Exclusion Criteria
* Previous operated cases
8 Years
12 Years
ALL
No
Sponsors
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Fayoum University
OTHER
Responsible Party
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Alshaimaa Ahmed shabaan
associate professor in oral & maxillofacial Surgery Department
Locations
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Faculty of Dentistry
Al Fayyum, , Egypt
Faculty of Dentistry
Cairo, , Egypt
Countries
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References
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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.
Ziegler 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.
Shabaan 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.
Other Identifiers
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BMC AlvCleft
Identifier Type: -
Identifier Source: org_study_id
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