Condition category
Musculoskeletal Diseases
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gert Meijer

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
AZU
Department of Oral Maxillofacial Surgery
Heidelberglaan 100
P.O. Box 85500
Utrecht
3584 CX
Netherlands
gmeijer@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Cultured mesenchymal stem cells differentiated into osteoblasts and seeded on scaffolds can induce bone formation.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Clinical feasability study

Primary study design

Interventional

Secondary study design

Other

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

VivescOs™

Primary outcome measures

Safety of VivescOs™ has been confirmed.

Secondary outcome measures

Efficacy of VivescOs™ is doubted.

Overall trial start date

08/11/2000

Overall trial end date

21/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Repair of the intra-oral defect was indicated as preparation for dental implant placement in a secondary stage.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

10

Participant 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.

Recruitment start date

08/11/2000

Recruitment end date

21/01/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

IsoTis NV (The Netherlands)

Sponsor details

Prof. Bronkhorstlaan 10-D
Bilthoven
3723 MB
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

IsoTis NV (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes