Bisphosphonate-coated Dental Implants

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University Hospital, Linkoeping.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT00767169

First received: October 3, 2008

Last updated: February 4, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2008

Last Updated Date

February 4, 2010

Start Date ^ICMJE

October 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00767169 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Marginal resorption on x-rays [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bisphosphonate-coated Dental Implants

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Edentatio (Toothlessness)

Intervention ^ICMJE

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

Study Arm (s)

Bisphosphonate-coated implant with internal control

Each patient receives two implants at the same time: one bisphosphonate-coated and one uncoated control. Thus each patients has an internal control.

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jahanmehr Abtahi, MD

jahan.abtahi@lio.se

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00767169

Other Study ID Numbers ^ICMJE

Tandskruv1

Has Data Monitoring Committee

Responsible Party

Per Aspenberg, Linköping university

Study Sponsor ^ICMJE

University Hospital, Linkoeping

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Per Aspenberg, MD, PhD

Linköping University

Information Provided By

University Hospital, Linkoeping

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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