Overview

This trial is active, not recruiting.

Conditions diabetes, dental implants
Phase phase 2
Sponsor University of Michigan
Start date November 2008
End date June 2010
Trial size 30 participants
Trial identifier NCT00933491, 2008-03

Summary

Dental implants are regarded as a standard of care in restoring missing teeth. Although there is a high prevalence of diabetics who receive dental implants, the relationship between dental implants and diabetes has not clearly been investigated.

A total of 30 subjects (15 patients with type II diabetes and 15 non-diabetes subjects) who have dental implants will be recruited. The purposes of this research study are: (1) to evaluate diabetes patients to determine risk factors for bone loss at dental implants and teeth; and (2) to evaluate bone-resorptive biomarkers (proteins related to bone loss) present in saliva and blood serum, comparing the two groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Type II Diabetes
Non-diabetics

Primary Outcomes

Measure
Gather pilot data on our ability to longitudinally evaluate partially edentulous patients afflicted by diabetes mellitus with functional dental implants to determine clinical risk factors for progressive alveolar bone resorption at implants and teeth.
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

Inclusion Criteria: - be at least 40 years old - have at least one dental implant that has been in function for at least 6 months - have at least 6 natural teeth - have good general oral health - not be pregnant or breastfeeding or planning to become pregnant within the next year - if you are a pre-menopausal woman you or your male partner must be surgically sterile or you must be using reliable birth control (i.e., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) now and throughout the study or abstain from sex throughout the study Exclusion Criteria: - not have an active oral infection, including periodontitis and rampant caries - not have a history of chronic systemic illness or infection, history of oral cancer, life expectancy of less than 5 years - not have had cancer treatment in the last 12 months

Additional Information

Official title Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus: A Feasibility Cohort Study
Principal investigator Tae-Ju Oh, DDS, MS
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Michigan.