Edentatio (Toothlessness)
Conditions
Keywords
Edentatio (Toothlessness)
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.
Interventions
DEVICEDental implant coating with a fibrinogen carrier for pamidronate and ibandronate
Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate compared with uncoated controls in the same mouth.
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Marginal resorption on x-rays | 1 year |
Countries
Sweden
Outcome results
None listed