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

Phase 3

Completed

• Conditions: Alveolar Bone Atrophy

• 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.

Study Timeline

• Study First Submitted: 2020-02-25
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Study Start: 2020-03-12
• Primary Completion: 2023-07-31
• Study Completion: 2024-07-31
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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.
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."

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

University of Bergen, Institute of Clonical Dentistry; 🇳🇴 Bergen, Hordaland, Norway

Universidad Complutense De Madrid; 🇪🇸 Madrid, Calle Fernando de Castro Rodriguez,, Spain

Universitat Internacional De Catalunya; 🇪🇸 Barcelona, Spain