The Effect of adult MSC on Bone Regeneration and Osseointegration of Dental Implants following a Sinus Augmentation Procedure

Phase 1

• Conditions: In patients with biltareral edentulous areas and resorbed alveolar processes in the maxilla a bilateral sinus augmentation with Bio-OssTM, CE certified (Geistlich Biomaterials, Wolhusen Switzerland) will be performed. In one side additionally autogenous stem cells, that were harvested from the proximal tibia 2 months before and cultivated over 2 months in vitro, will be applied in the test sinus.Histomorphometric analysis will be performed with Biopsies after 3 and 6 months.

• Registration Number: EUCTR2006-003551-20-AT
• Lead Sponsor: Department of Oral Surgery Dental School Med. Univ. Graz, Austria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-21
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Healthy oral and medical status.
Bilateral edentulous areas in the maxilla

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Agressive periodontitis, poor oral hygiene status, medical conditions that do not allow oral surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the effect of autgenous MSC on bone healing in the maxilla;Secondary Objective: Evaluation of MSC on osseointegration of dental implants. Evaluation of donorsites for stem cells (tibia/maxilla/blood);Primary end point(s): The planned duration of the study is approx. 18 months and ends with the evaluation of osseointegration of the dental implants 9 months after implant insertion.