Edentulous Alveolar Ridge Clinical Trial
Official title:
Bone Marrow Aspirate Concentrate(BMAC) on 3D Printed Polycaprolactone (PCL) Scaffold for Ridge Augmentation of Horizontal Alveolar Defects in Aesthetic Zone (Clinical Case Series Study)
BMAC is used on 3D printed PCL scaffold for horizontal ridge augmentation in aesthetic zone , BMAC contains MSCs which can differentiate in osteogenic medium into osteoblasts which can lay down bone
Status | Recruiting |
Enrollment | 7 |
Est. completion date | August 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patient who require horizontal ridge augmentation in the aesthetic zone (Maxillary anterior and premolar area) with defect size of one or two lost teeth. - Patients in the age range of 18 years and above. - ASA physical status I and II. - Patients willing to be a part of the study and ready to give their consent in writing for the same. Exclusion Criteria: - Local criteria: - Untreated gingivitis, periodontitis. - Insufficient oral hygiene. - Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site. Systemic criteria: - Systemic disorders. - Smoking. - Bone pathology. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Cairo university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. eCollection 2016 Jan. — View Citation
Cotter EJ, Wang KC, Yanke AB, Chubinskaya S. Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence. Cartilage. 2018 Apr;9(2):161-170. doi: 10.1177/1947603517741169. Epub 2017 Nov 10. — View Citation
Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. — View Citation
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Sanz M, Dahlin C, Apatzidou D, Artzi Z, Bozic D, Calciolari E, De Bruyn H, Dommisch H, Donos N, Eickholz P, Ellingsen JE, Haugen HJ, Herrera D, Lambert F, Layrolle P, Montero E, Mustafa K, Omar O, Schliephake H. Biomaterials and regenerative technologies used in bone regeneration in the craniomaxillofacial region: Consensus report of group 2 of the 15th European Workshop on Periodontology on Bone Regeneration. J Clin Periodontol. 2019 Jun;46 Suppl 21:82-91. doi: 10.1111/jcpe.13123. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Width gain | The width of the augmented alveolar ridge measured from the Cone Beam Computed Tomography in millimeters | 6 months | |
Secondary | Percentage of bone formation in the bone biopsy | Bone biopsy is obtained after 6 months and subjected to histomorphometric analysis | 6 months |
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