A clinical feasibility study to evaluate the effectiviness and safety of VivescOs TM as bone graft for reconstruction of intra-oral osseous defects.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24005

Enrollment

Registered

2006-05-26

Start date

2000-11-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-oral defects, due to loss of teeth/molars after trauma or extraction, were reconstructed with VivescOs.

Interventions

"VisvescOs" and "tissue engineered bone". "Preoperatively, 4 weeks before the implantation procedure, a aspiration biopsy will be taken. Post-operatively patients will be evaluated using radiographi

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety of VivescOs has been confirmed.	—

Secondary

Measure	Time frame
Efficacy of VivescOs is doubted.	—

Contacts

Public ContactGert Meijer

University Medical Center Utrecht (UMCU), AZU,Department of Oral Maxillofacial Surgery, Heidelberglaan 100, P.O. Box 85500,

gmeijer@azu.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)