Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
- Conditions
- Alveolar Bone Atrophy
- Interventions
- Procedure: Autologous bone graftCombination Product: Advanced medicinal Therapy (MSC combined with biomaterial)
- Registration Number
- NCT04297813
- Lead Sponsor
- University of Bergen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Autologous bone graft The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge. Test Advanced medicinal Therapy (MSC combined with biomaterial) Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate
- Primary Outcome Measures
Name Time Method Change in bone width 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 Outcome Measures
Name Time Method Pain postoperatively in the two different treatments 21 months Assessed by VAS scale, the scale goes from 0 to 100, 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Radiological examination of bone volume 21 months To evaluate the formation of the new bone by assessing if it is possible to insert an implant in the reconstructed area 5 months after the grafting procedure. This decision will be made based on radiological examination of bone volume by means of 3D CBCT images captured immediately prior to implant placement, 5-6 months after the regenerative surgery.
Trial Locations
- Locations (6)
Syddansk Universitet SDU (University Hospital of Southern Denmark)
🇩🇰Odense, Denmark
Assistance Publique - Hôpitaux De Paris
🇫🇷Créteil, France
CHU Nantes, Centre de Soins Dentaires
🇫🇷Nantes, France
Universidad Complutense De Madrid
🇪🇸Madrid, Calle Fernando De Castro Rodriguez,, Spain
Universitat Internacional De Catalunya
🇪🇸Barcelona, Spain
University of Bergen, Institute of Clonical Dentistry
🇳🇴Bergen, Hordaland, Norway