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NCT00767169 Clinical Trial

Bisphosphonate-coated Dental Implants

Edentatio (Toothlessness) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00767169
Other study ID # Tandskruv1
Secondary ID
Status Completed
Phase Phase 2
First received October 3, 2008
Last updated December 9, 2013
Start date October 2008
Est. completion date June 2011

Study information
Verified date December 2013
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• Dental 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.

Locations
Country Name City State
Sweden Department of Oral & maxillofacial surgery, University Hospital. Linköping

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Abtahi J, Tengvall P, Aspenberg P. A bisphosphonate-coating improves the fixation of metal implants in human bone. A randomized trial of dental implants. Bone. 2012 May;50(5):1148-51. doi: 10.1016/j.bone.2012.02.001. Epub 2012 Feb 10. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient. 6 months No
Secondary Marginal resorption on x-rays 1 year Yes