Bisphosphonate-coated Dental Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00767169
First received: October 3, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Edentatio (Toothlessness)
Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Marginal resorption on x-rays [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: coated implant and control 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767169

Locations
Sweden
Department of Oral & maxillofacial surgery, University Hospital.
Linköping, Sweden, SE-581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Study Chair: Per Aspenberg, MD, PhD Linköping university
  More Information

Publications:
Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00767169     History of Changes
Other Study ID Numbers: Tandskruv1
Study First Received: October 3, 2008
Last Updated: December 9, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:
Edentatio (Toothlessness)

Additional relevant MeSH terms:
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014