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| Name | Class |
|---|---|
| University of Ulm | OTHER |
| Haukeland University Hospital | OTHER |
| Université de Nantes | OTHER |
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This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant into the new bone in a prosthetically guided position.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmentation of new alveolar bone | Experimental | Augmentation of atrophied alveolar ridge with mesenchymal stem cells( MSC) and bis calcium phosphate(BCP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCP with autologous mesenchymal stem cells (MSC). | Drug | Augmentation of narrow alveolar ridge with BCP and MSC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments. | CBCT | Four to six months post augmentation |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability | Implant stability measurement using the Ostell system | 12 months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety of MSC in patients. Adverse events |
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Inclusion Criteria:Patients presenting with an indication for an implant and wanting implant-borne prosthetic restoration.
General criteria:
Exclusion Criteria:
ocal criteria:
General criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilie Gjerde, DDS | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Dentistry, University of Bergen | Bergen | Hordaland | 5008 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30092840 | Result | Gjerde C, Mustafa K, Hellem S, Rojewski M, Gjengedal H, Yassin MA, Feng X, Skaale S, Berge T, Rosen A, Shi XQ, Ahmed AB, Gjertsen BT, Schrezenmeier H, Layrolle P. Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial. Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9. |
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| 5 years |