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Clinical Trials/NCT00767169
NCT00767169
Completed
Phase 2

Bisphosphonate-coated Dental Implants

University Hospital, Linkoeping1 site in 1 country16 target enrollmentOctober 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Edentatio (Toothlessness)
Sponsor
University Hospital, Linkoeping
Enrollment
16
Locations
1
Primary Endpoint
Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
June 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Linkoeping
Responsible Party
Principal Investigator
Principal Investigator

Per Aspenberg

professor

University Hospital, Linkoeping

Eligibility Criteria

Inclusion Criteria

  • Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.

Exclusion Criteria

  • Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
  • Local exclusion criteria were: previous tumour, trauma and surgery.
  • Also patients with Cawood \& Howell class IV - VI maxilla-bone were excluded.

Outcomes

Primary Outcomes

Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.

Time Frame: 6 months

Secondary Outcomes

  • Marginal resorption on x-rays(1 year)

Study Sites (1)

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