Initial Fixation of Bisphosphonate-coated Dental Implants

• Sponsor: Per Aspenberg (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02044978
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2014
• Anticipated Primary Completion Date: Jan 1, 2016
• Anticipated Study Completion Date: Jan 1, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Vibration frequency ratio [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Käkcentralen	Linköping		Sweden	58185
2	Tandläkarhuset	Linköping		Sweden	58227

Sponsors and Collaborators

• Per Aspenberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
• ClinicalTrials.gov Identifier: NCT02044978
• Other Study ID Numbers: Tandskruv tidsserie
• First Posted: Jan 24, 2014
• Last Update Posted: Jun 9, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Zoledronic Acid

Study Results

No Results Posted as of Jun 9, 2015