A clinical feasibility study to evaluate the effectiveness and safety of VivescOs™ as bone graft for reconstruction of intra-oral osseous defects
| ISRCTN | ISRCTN92152389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92152389 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/09/2006
- Registration date
- 26/09/2006
- Last edited
- 10/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gert Meijer
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
AZU
Department of Oral Maxillofacial Surgery
Heidelberglaan 100
P.O. Box 85500
Utrecht
3584 CX
Netherlands
| gmeijer@azu.nl |
Study information
| Study design | Clinical feasability study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Other |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Cultured mesenchymal stem cells differentiated into osteoblasts and seeded on scaffolds can induce bone formation. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Intra-oral bone defects, loss of teeth/molars |
| Intervention | VivescOs™ versus tissue engineered bone. Preoperatively, four weeks before the implantation procedure, a aspiration biopsy will be taken. Post-operatively patients will be evaluated using radiographic analysis by OphtoPantomoGrams (OPG), histological analysis by biopsy specimens and clinical evaluation of functionality at three months, six months, nine months, 12 months and 15 months after surgery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | VivescOs™ |
| Primary outcome measure | Safety of VivescOs™ has been confirmed. |
| Secondary outcome measures | Efficacy of VivescOs™ is doubted. |
| Overall study start date | 08/11/2000 |
| Completion date | 21/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | Repair of the intra-oral defect was indicated as preparation for dental implant placement in a secondary stage. |
| Key exclusion criteria | 1. Presence of local or systemic disease; 2. Pregnancy, cancertherapy; 3. Previous participation in another trial within 30 days; 4. Known hypersensitivity for penicillin, streptomycin. |
| Date of first enrolment | 08/11/2000 |
| Date of final enrolment | 21/01/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
IsoTis NV (The Netherlands)
Industry
Industry
Prof. Bronkhorstlaan 10-D
Bilthoven
3723 MB
Netherlands
"ROR" |
https://ror.org/04qce9v53 |
|---|
Funders
Funder type
Industry
IsoTis NV (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
