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 |
| Protocol serial number | N/A |
| Sponsor | IsoTis NV (The Netherlands) |
| Funder | IsoTis NV (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Clinical feasability study |
| Secondary study design | Other |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | VivescOs™ |
| Primary outcome measure(s) |
Safety of VivescOs™ has been confirmed. |
| Key secondary outcome measure(s) |
Efficacy of VivescOs™ is doubted. |
| Completion date | 21/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
