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OpenTrials
Completed

NCT Number: NCT00767169

Bisphosphonate-coated Dental Implants

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.

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Key information

Conditions

Edentatio (Toothlessness)

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oral & maxillofacial surgery, University Hospital.

Linköping, SE-581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate

Device

Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate compared with uncoated controls in the same mouth.

Primary outcomes

  1. Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.

    Time frame: 6 months

Secondary outcomes

  1. Marginal resorption on x-rays

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2008
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.