Bisphosphonate-Coated Dental Implants
Information source: University Hospital, Linkoeping
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Edentatio (Toothlessness)
Intervention: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate (Device)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital, Linkoeping Official(s) and/or principal investigator(s):
Per Aspenberg, MD, PhD, Study Chair, Affiliation: Linköping University
Overall contact:
Jahanmehr Abtahi, MD, Email: jahan.abtahi@lio.se
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
Secondary outcome: Marginal resorption on x-rays
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jahanmehr Abtahi, MD, Email: jahan.abtahi@lio.se
Department of Oral & maxillofacial surgery, University Hospital., Linköping SE-581 85, Sweden; Recruiting
Jahanmehr Abtahi, MD
Additional Information
Starting date: October 2008
Last updated: October 3, 2008
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