Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

This study has been completed.
Information provided by (Responsible Party):
Tae-Ju Oh, University of Michigan
ClinicalTrials.gov Identifier:
First received: July 2, 2009
Last updated: October 7, 2015
Last verified: October 2015

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 32 subjects (14 patients with type II diabetes and 18 non-diabetes subjects) who have dental implants were recruited. The purposes of this research study were: (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
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

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Radiographic Bone Level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean radiographic bone level at 12 months

  • Radiographic Bone Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Mean radiographic bone level at baseline

Biospecimen Retention:   Samples Without DNA
saliva and plaque biofilm

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Type II Diabetes

Detailed Description:


Regulators of peri-implant bone loss in patients with diabetes appear to involve multiple risk factors that have not been clearly elucidated. This study was conducted to explore putative local etiologic factors on implant bone loss in relation to type 2 diabetes mellitus, including clinical, microbial, salivary biomarker, and psychosocial factors.


Thirty-two subjects (divided into type 2 diabetes mellitus and non-diabetic controls), having at least one functional implant and six teeth, were enrolled in a 1-year longitudinal investigation. Analyses of clinical measurements and standardized intra-oral radiographs, saliva and serum biomarkers (via protein arrays for 20 selected markers), and plaque biofilm (via qPCR for eight periodontal pathogens) were performed at baseline and 1 year. In addition, the subjects were asked to respond to questionnaires to assess behavioral and psychosocial variables.


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

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

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

Additional Information:
Responsible Party: Tae-Ju Oh, Clinical Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00933491     History of Changes
Other Study ID Numbers: 2008-03
Study First Received: July 2, 2009
Results First Received: July 30, 2015
Last Updated: October 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:

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

ClinicalTrials.gov processed this record on November 25, 2015