Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Alveolar Bone Atrophy

Intervention / Treatment
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* Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)
* Procedure: Autologous bone graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with advanced therapy medicinal product
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge. | Procedure: Autologous bone graft<br>* Augmentation of the alveolar ridge with bone graft<br>|
| Experimental: Test<br>Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate | Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)<br>* Augmentation of alveolar ridge with MSC and biomaterial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone width | 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 | 0-5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain postoperatively in the two different treatments | 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. | 21 months | 
| Radiological examination of bone volume | 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. | 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSC, Maxilla, mandible,, RCT, Bone regeneration, Multicenter