Initial Fixation of Bisphosphonate-coated Dental Implants

Phase 2

• Conditions: Pre-integration Failure of Dental Implant
• Interventions: Device: Zoledronate-coated dental implant

• Registration Number: NCT02044978
• Lead Sponsor: Per Aspenberg

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.

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09
• Primary Completion: 2016-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bisphosphonate implant	Zoledronate-coated dental implant	Dental implant coated with zoledronate Note: Both arms in each patient (2 implants)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Käkcentralen; 🇸🇪 Linköping, Sweden

Tandläkarhuset; 🇸🇪 Linköping, Sweden