Reconstruction of Jaw Bone Using Mesenchymal Stem Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02751125|
Recruitment Status : Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bone Atrophy||Drug: BCP with autologous mesenchymal stem cells (MSC).||Phase 1|
Eleven patients presenting with the need of an implant retained restoration in the posterior mandibula and an alveolar ridge of maximum 4.5 mm width.
A clinical examination, x- rays and Cone Beam CT(CBCT) are accessed. A sample of the patients` bone marrow is extracted from the posterior alveolar ridge, immediately shipped to the collaborating good clinical practice (GCP) cell laboratory for cell expansion, and returned after 21 days. The stem cells mixed with Bi Calcium Phosphate (BCP) are then used to augment the alveolar ridge. The material is covered with a titanium reinforced membrane before closure of the site. After four to six months a bone biopsy is performed and implants are installed in the regenerated bone.
The patient will be followed after 1, 2, 3, and 5 years where implant stability will be assessed. Furthermore the new formed bone will be clinically and radiologically assessed at the same time.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Jaw Bone Reconstruction Using a Combination of Autologous Mesenchymal Stem Cells and Biomaterial Prior to Dental Implant Placement|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: Augmentation of new alveolar bone
Augmentation of atrophied alveolar ridge with mesenchymal stem cells( MSC) and bis calcium phosphate(BCP)
Drug: BCP with autologous mesenchymal stem cells (MSC).
Augmentation of narrow alveolar ridge with BCP and MSC
Other Name: MSC and BCP
- Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments. [ Time Frame: Four to six months post augmentation ]CBCT
- Implant stability [ Time Frame: 12 months ]Implant stability measurement using the Ostell system
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 5 years ]Safety of MSC in patients. Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751125
|Institute of Clinical Dentistry, University of Bergen|
|Bergen, Hordaland, Norway, 5008|
|Principal Investigator:||Cecilie Gjerde, DDS||University of Bergen|