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

University of Bergen48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alveolar Bone Atrophy

Interventions

Advanced medicinal Therapy (MSC combined with biomaterial)COMBINATION_PRODUCT

Augmentation of alveolar ridge with MSC and biomaterial

Autologous bone graftPROCEDURE

Augmentation of the alveolar ridge with bone graft

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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

University of Bergen, Institute of Clonical Dentistry

Bergen, Hordaland, Norway

Outcomes

Primary Outcomes

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

Time frame: 0-5 months

Secondary Outcomes

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."

Time frame: 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.

Time frame: 21 months

Data from ClinicalTrials.gov

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