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

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.

Conditions

• Alveolar Bone Atrophy

Interventions

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

Sponsors & Collaborators

• University of Bergen

  lead OTHER

• Université de Nantes

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• Universidad Complutense de Madrid

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Universitat Internacional de Catalunya

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• European Commission

  collaborator OTHER

Principal Investigators

• Mariano Sanz, Professor · Universidad Complutense de Madrid

• Else Marie Pinholt, Professor · Syddansk Universitet SDU (University Hospital of Southern Denmark)

• Federico Hernandez-Alfaroo, Professor · Universitat Internacional de Catalunya

• Alain Hoornaert, DDS · CHU Nantes, Centre de Soins Dentaires

• Frederik Gaultier, PhD/DDS · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-12

Primary Completion

2023-07-31

Completion

2024-07-31

Countries

• Denmark
• France
• Norway
• Spain

Study Locations