Initial Fixation of Bisphosphonate-coated Dental Implants

Per Aspenberg

Status and phase: Unknown; Phase 2

Conditions: Pre-integration Failure of Dental Implant

Treatments: Device: Zoledronate-coated dental implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02044978

Tandskruv tidsserie

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Bisphosphonate implant

Active Comparator group

Description:

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

Treatment:

Device: Zoledronate-coated dental implant

control

Placebo Comparator group

Description:

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