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Bisphosphonate-coated Dental Implants

Information source: University Hospital, Linkoeping
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: University Hospital, Linkoeping

Official(s) and/or principal investigator(s):
Per Aspenberg, MD, PhD, Study Chair, Affiliation: Linköping university

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Department of Oral & maxillofacial surgery, University Hospital., Linköping SE-581 85, Sweden
Additional Information

Starting date: October 2008
Last updated: December 9, 2013

Page last updated: August 23, 2015

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