An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro

Dentsply Sirona Implants and Consumables4 sites in 4 countries54 target enrollmentJanuary 1999

ConditionsJaw, Edentulous

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jaw, Edentulous
Sponsor: Dentsply Sirona Implants and Consumables
Enrollment: 54
Locations: 4
Primary Endpoint: Implant survival
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 1999

End Date

December 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dentsply Sirona Implants and Consumables

Eligibility Criteria

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