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

  • End date
    Sep 23, 2024
  • participants needed
  • sponsor
    University of Bergen
Updated on 28 February 2022
dental implantation
bone graft
Accepts healthy volunteers


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.


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.

Condition Alveolar Bone Atrophy
Treatment Autologous bone graft, Advanced medicinal Therapy (MSC combined with biomaterial)
Clinical Study IdentifierNCT04297813
SponsorUniversity of Bergen
Last Modified on28 February 2022


Yes No Not Sure

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
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