Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Bergen
- Enrollment
- 48
- Locations
- 12
- Primary Endpoint
- Change in bone width
Study Overview
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 placement in comparison to standard autologous bone block grafting.
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 place a dental implant. The test objects will have augmentation using autologous mesenchymal stromal cells and a biomaterial, biphasic Calcium Phosphate. The control is the traditional bone block from the ramus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Change in bone width
Time Frame: 0-5 months
Changes in linear measurements of bone width measured by CBCT.Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement
Secondary Outcomes
- Radiological examination of bone volume(21 months)
- Pain postoperatively in the two different treatments(21 months)