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
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