Bisphosphonate-coated Dental Implants
Phase 2
Completed
- Conditions
- Edentatio (Toothlessness)
- Interventions
- Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate
- Registration Number
- NCT00767169
- Lead Sponsor
- University Hospital, Linkoeping
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description coated implant and control Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate -
- Primary Outcome Measures
Name Time Method Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient. 6 months
- Secondary Outcome Measures
Name Time Method Marginal resorption on x-rays 1 year
Trial Locations
- Locations (1)
Department of Oral & maxillofacial surgery, University Hospital.
🇸🇪Linköping, Sweden