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Bisphosphonate-coated Dental Implants

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ClinicalTrials.gov Identifier: NCT00767169
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Marginal resorption on x-rays [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Linkoeping University

Publications:
Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00767169     History of Changes
Other Study ID Numbers: Tandskruv1
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

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

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