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Clinical Trials/NCT00748670
NCT00748670
Terminated
Not Applicable

An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality

Dentsply Sirona Implants and Consumables3 sites in 2 countries23 target enrollmentSeptember 1999
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ConditionsJaw, EdentulousPoor Bone Quality

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Jaw, Edentulous
Sponsor
Dentsply Sirona Implants and Consumables
Enrollment
23
Locations
3
Primary Endpoint
Implant survival
Status
Terminated
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).

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
September 1999
End Date
October 2006
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
  • •Bone quality class III or IV, (according to Lekholm \& Zarb16)
  • •Willing to give signed informed consent

Exclusion Criteria

  • •Need for bone augmentation of the maxilla
  • •Tobacco smoking more than 5 cigarettes/day
  • •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
  • •Bruxism or other parafunctional activity

Outcomes

Primary Outcomes

Implant survival

Time Frame: Continuously during 5,5 years after implant placement

Study Sites (3)

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