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Initial Fixation of Bisphosphonate-coated Dental Implants

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ClinicalTrials.gov Identifier: NCT02044978
Recruitment Status : Unknown
Verified June 2015 by Per Aspenberg, University Hospital, Linkoeping.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping

Brief Summary:
16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.

Condition or disease Intervention/treatment Phase
Pre-integration Failure of Dental Implant Device: Zoledronate-coated dental implant Phase 2

Detailed Description:
The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Initial Fixation of Bisphosphonate-coated Dental Implants
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bisphosphonate implant
Dental implant coated with zoledronate Note: Both arms in each patient (2 implants)
Device: Zoledronate-coated dental implant
Placebo Comparator: control
Dental implant without coating Note: Both arms in each patient (2 implants)



Primary Outcome Measures :
  1. Vibration frequency ratio [ Time Frame: 4 and 6 weeks ]
    Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for 4 and 6 weeks will be used.


Secondary Outcome Measures :
  1. Marginal resorption [ Time Frame: 8 weeks ]
    Radiographic loss of bone at the margin of the implant, measured as difference in mm from the superficial bone contour between insertion and 8 weeks.

  2. Vibration: area under the curve [ Time Frame: 2-8 weeks ]
    Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for all weeks will be used.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Need for dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy

Exclusion Criteria:

Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.


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): NCT02044978


Contacts
Contact: Jahan Abtahi, MD, PhD jahan.abtahi@lio.se
Contact: Per Aspenberg, MD, PhD per.aspenberg@liu.se

Locations
Sweden
Käkcentralen Recruiting
Linköping, Sweden, 58185
Contact: Jahan Abtahi, MD PhD       jahan.abtahi@lio.se   
Principal Investigator: Jahan Abtahi, MD PhD         
Tandläkarhuset Recruiting
Linköping, Sweden, 58227
Contact: Jahan Abtahi, MD PhD       jahan.abtahi@lio.se   
Sponsors and Collaborators
Per Aspenberg

Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02044978     History of Changes
Other Study ID Numbers: Tandskruv tidsserie
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015

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