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

University of Bergen

Status and phase: Enrolling; Phase 3

Conditions: Alveolar Bone Atrophy

Treatments: Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial); Procedure: Autologous bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT04297813

2018-001227-39 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control

Active Comparator group

Description:

The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.

Treatment:

Procedure: Autologous bone graft

Test

Experimental group

Description:

Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate

Treatment:

Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)