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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00748397
Other study ID # YA-MMF-0002
Secondary ID
Status Terminated
Phase N/A
First received September 5, 2008
Last updated September 5, 2008
Start date January 1999

Study information

Verified date September 2008
Source Dentsply Implants
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics CommissionSpain: Comité Ético de Investigación ClínicaSweden: Regional Ethical Review BoardUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.


Recruitment information / eligibility

Status Terminated
Enrollment 54
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18-75 years of age

- Sufficient amount of bone to give good support for implants of at least 9 mm length.

- Willing to give signed informed consent

Exclusion Criteria:

- Any systemic disease or condition that would compromise post-operative healing and/or osseointegration

- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration

- Unable or unwilling to return for follow-up visits

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Fixture MicroThread (Micro-Macro)
Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.

Locations

Country Name City State
Germany Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität Heidelberg
Spain Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia Madrid
Sweden Käkkirurgiska kliniken, Universitetssjukhuset MAS Malmö
United States Louisiana State University Medical Center, School of Dentistry New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Germany,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant survival Continuously during 5,5 years after implant placement No
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