Status:
COMPLETED
Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
Lead Sponsor:
University of Bergen
Collaborating Sponsors:
Université de Nantes
University of Ulm
Conditions:
Alveolar Bone Atrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placem...
Detailed Description
A phase III multi center clinical trial, randomized and controlled.The study subject is lacking one or more sheet behind the canine in the upper or lower jaw, and the alveolar ridge is too narrow to p...
Eligibility Criteria
Inclusion
- Healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width.
Exclusion
- General contraindications for dental and/or surgical treatments
- Contraindications for both bone marrow harvesting and bone grafts
- History of any malignant diseases
- Concurrent or previous radiotherapy of head and neck region
- History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
- Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient's history and concurrent HbA1c levels (HbA1c \> 53 mmol/mol).
- Inflammatory and autoimmune disease of the oral cavity.
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04297813
Start Date
March 12 2020
End Date
July 31 2024
Last Update
June 29 2025
Active Locations (6)
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1
Syddansk Universitet SDU (University Hospital of Southern Denmark)
Odense, Denmark, 5230
2
Assistance Publique - Hôpitaux De Paris
Créteil, France, 94010
3
CHU Nantes, Centre de Soins Dentaires
Nantes, France, 44000
4
University of Bergen, Institute of Clonical Dentistry
Bergen, Hordaland, Norway, 5009