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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001227-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Université de Nantes | OTHER |
| University of Ulm | OTHER |
| Universidad Complutense de Madrid | OTHER |
| University of Aarhus |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge. |
|
| Test | Experimental | Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced medicinal Therapy (MSC combined with biomaterial) | Combination Product | Augmentation of alveolar ridge with MSC and biomaterial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone width | Changes in linear measurements of bone width measured by CBCT.Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement | 0-5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain postoperatively in the two different treatments | Assessed by VAS scale, the scale goes from 0 to 100, 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." | 21 months |
| Radiological examination of bone volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz, Professor | Universidad Complutense de Madrid | Principal Investigator |
| Else Marie Pinholt, Professor | Syddansk Universitet SDU (University Hospital of Southern Denmark) | Principal Investigator |
| Federico Hernandez-Alfaroo, Professor | Universitat Internacional de Catalunya | Principal Investigator |
| Alain Hoornaert, DDS | CHU Nantes, Centre de Soins Dentaires | Principal Investigator |
| Frederik Gaultier, PhD/DDS | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syddansk Universitet SDU (University Hospital of Southern Denmark) | Odense | 5230 | Denmark | |||
| Assistance Publique - Hôpitaux De Paris |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30092840 | Background | 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. | |
| 30926359 |
| Label | URL |
|---|---|
| Webpage for the clinical trial | View source |
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De-identified individual participants data for all primary and secondary outcome measures will be made available
Data will be available after study completion
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement
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| OTHER |
| Universitat Internacional de Catalunya | OTHER |
| Assistance Publique - Hôpitaux de Paris | OTHER |
| European Commission | OTHER |
Randomized controlled trial with advanced therapy medicinal product
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| Autologous bone graft | Procedure | Augmentation of the alveolar ridge with bone graft |
|
To evaluate the formation of the new bone by assessing if it is possible to insert an implant in the reconstructed area 5 months after the grafting procedure. This decision will be made based on radiological examination of bone volume by means of 3D CBCT images captured immediately prior to implant placement, 5-6 months after the regenerative surgery. |
| 21 months |
| Créteil |
| 94010 |
| France |
| CHU Nantes, Centre de Soins Dentaires | Nantes | 44000 | France |
| University of Bergen, Institute of Clonical Dentistry | Bergen | Hordaland | 5009 | Norway |
| Universidad Complutense De Madrid | Madrid | Calle Fernando de Castro Rodriguez, | 28040 | Spain |
| Universitat Internacional De Catalunya | Barcelona | 08195 | Spain |
| Rojewski MT, Lotfi R, Gjerde C, Mustafa K, Veronesi E, Ahmed AB, Wiesneth M, Korper S, Sensebe L, Layrolle P, Hellem S, Schrezenmeier H. Translation of a standardized manufacturing protocol for mesenchymal stromal cells: A systematic comparison of validation and manufacturing data. Cytotherapy. 2019 Apr;21(4):468-482. doi: 10.1016/j.jcyt.2019.03.001. Epub 2019 Mar 27. |
| 40844304 | Derived | Sanz M, Gjerde C, Gjertsen BT, Ortiz-Vigon A, Sanchez N, Hoornaert A, Caballe-Serrano J, Giralt-Hernando M, Gaultier F, Reinald N, Pinholt EM, Rojewski M, Rouard H, Chevallier N, Mohamed-Ahmed S, Shi X, Shi TJ, Schrezenmeier H, Layrolle P, Mustafa K. Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial. Clin Oral Implants Res. 2025 Nov;36(11):1498-1514. doi: 10.1111/clr.70025. Epub 2025 Aug 22. |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D001672 | Biocompatible Materials |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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