Bisphosphonate-coated Dental Implants

University Hospital, Linkoeping

Status and phase: Completed; Phase 2

Conditions: Edentatio (Toothlessness)

Treatments: Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00767169

Tandskruv1

Details and patient eligibility

About

Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.

Exclusion criteria

• Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
• Local exclusion criteria were: previous tumour, trauma and surgery.
• Also patients with Cawood & Howell class IV - VI maxilla-bone were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 1 patient group

coated implant and control

Experimental group

Treatment:

Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate