Trial record 8 of 51 for:    Open Studies | "Dental Implants"

Initial Fixation of Bisphosphonate-coated Dental Implants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT02044978
First received: January 22, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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 Intervention Phase
Pre-integration Failure of Dental Implant
Device: Zoledronate-coated dental implant
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
Official Title: Initial Fixation of Bisphosphonate-coated Dental Implants

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Vibration frequency ratio [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Marginal resorption [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Vibration: area under the curve [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 16
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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).

  Eligibility

Genders Eligible for Study:   Both
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.

  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: 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
  More Information

No publications provided

Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02044978     History of Changes
Other Study ID Numbers: Tandskruv tidsserie
Study First Received: January 22, 2014
Last Updated: January 22, 2014
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on August 28, 2014