Initial Fixation of Bisphosphonate-coated Dental Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pre-integration Failure of Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bisphosphonate implant

Dental implant coated with zoledronate Note: Both arms in each patient (2 implants)

Group Type ACTIVE_COMPARATOR

Zoledronate-coated dental implant

Intervention Type DEVICE

control

Dental implant without coating Note: Both arms in each patient (2 implants)

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Zoledronate-coated dental implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No