BMAC on PCL Scaffold for Ridge Augmentation

NCT05241548 | Completed DMC

• 1 other identifier: BMAC 3D PCL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Loss in Jaw; Edentulous Alveolar Ridge

Keywords

Ridge augmentation, BMAC , PCL

Outcome Measures

Primary Outcomes (1)

• Bone Width gain

  The width of the augmented alveolar ridge measured from the Cone Beam Computed Tomography in millimeters

  6 months

Secondary Outcomes (1)

• Percentage of bone formation in the bone biopsy

  6 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

Ridge augmentation of horizontally deficient alveolar ridge in aesthetic zone by BMAC on PCL scaffold

Procedure: BMAC on PCL Scaffold

Interventions

BMAC on PCL Scaffold PROCEDURE

Horizontal ridge augmentation in aesthetic zone by using bone marrow aspirate concentrate on PCL scaffold

Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, 12311, Egypt

Location

Related Publications (9)

• 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.

  PMID: 26798765 BACKGROUND

• 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.

  PMID: 29126349 BACKGROUND

• 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. doi: 10.1080/14653240600855905.

  PMID: 16923606 BACKGROUND

• Jager M, Jelinek EM, Wess KM, Scharfstadt A, Jacobson M, Kevy SV, Krauspe R. Bone marrow concentrate: a novel strategy for bone defect treatment. Curr Stem Cell Res Ther. 2009 Jan;4(1):34-43. doi: 10.2174/157488809787169039.

  PMID: 19149628 BACKGROUND

• McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.

  PMID: 17335361 BACKGROUND

• 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.

  PMID: 31215114 BACKGROUND

• Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.

  PMID: 6578906 BACKGROUND

• Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part II. Prosthetic/periodontal interrelationships. Compend Contin Educ Dent (Lawrenceville). 1983 Nov-Dec;4(6):549-62. No abstract available.

  PMID: 6321099 BACKGROUND

• Shanbhag S, Suliman S, Pandis N, Stavropoulos A, Sanz M, Mustafa K. Cell therapy for orofacial bone regeneration: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:162-182. doi: 10.1111/jcpe.13049.

  PMID: 30623455 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: February 15, 2022
• Study Start: January 15, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

EG (1)