Bisphosphonate-Coated Dental Implants - Full Text View

Sponsored by:	University Hospital, Linkoeping
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00767169

Purpose

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.

Condition	Intervention	Phase
Edentatio (Toothlessness)	Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate	Phase II

MedlinePlus related topics: X-Rays

Drug Information available for: Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	16
Study Start Date:	October 2008

Arms	Assigned Interventions
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.	Device: Dental implant coating with a fibrinogen carrier for pamidronate and ibandronate

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767169

Contacts

Contact: Jahanmehr Abtahi, MD

jahan.abtahi@lio.se

Locations

Sweden
Department of Oral & maxillofacial surgery, University Hospital.	Recruiting
Linköping, Sweden, SE-581 85
Contact: Jahanmehr Abtahi, MD

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

Study Chair:

Per Aspenberg, MD, PhD

Linköping University

More Information

Responsible Party:	Linköping university ( Per Aspenberg )
Study ID Numbers:	Tandskruv1
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00767169
Health Authority:	Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:

Edentatio (Toothlessness)

Study placed in the following topic categories:

Diphosphonates
Ibandronic acid
Pamidronate

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009