NCT00767169
Completed
Phase 2
Bisphosphonate-coated Dental Implants
University Hospital, Linkoeping1 site in 1 country16 target enrollmentOctober 2008
ConditionsEdentatio (Toothlessness)
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.
Investigators
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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