NCT04297813

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alveolar Bone Atrophy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Advanced medicinal Therapy (MSC combined with biomaterial)	Augmentation of alveolar ridge with MSC and biomaterial
PROCEDURE	Autologous bone graft	Augmentation of the alveolar ridge with bone graft

Timeline

• Start date: 2020-03-12
• Primary completion: 2023-07-31
• Completion: 2024-07-31
• First posted: 2020-03-06
• Last updated: 2025-06-29

Locations

6 sites across 4 countries: Denmark, France, Norway, Spain