Text Size

Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00933491
First received: July 2, 2009
Last updated: June 17, 2010
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Phase
Diabetes
Dental Implants
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus: A Feasibility Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

saliva and plaque biofilm


Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetic
Type II Diabetes
Control
Non-diabetics

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Type II diabetics and non diabetics with dental implants

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933491

Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Tae-Ju Oh, DDS, MS University of Michigan
  More Information

Additional Information:
University of Michigan Clinical Research Database homepage  This link exits the ClinicalTrials.gov site
University of Michigan Center for Oral Health Research  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tae-Ju Oh, University of Michigan
ClinicalTrials.gov Identifier: NCT00933491     History of Changes
Other Study ID Numbers: 2008-03
Study First Received: July 2, 2009
Last Updated: June 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
healthy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013