Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933491
Recruitment Status : Completed
First Posted : July 7, 2009
Results First Posted : November 4, 2015
Last Update Posted : November 4, 2015
Information provided by (Responsible Party):
Tae-Ju Oh, University of Michigan

Brief 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 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 or disease

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.

Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus: A Feasibility Cohort Study
Study Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Type II Diabetes

Primary Outcome Measures :
  1. Radiographic Bone Level [ Time Frame: 12 months ]
    Mean radiographic bone level at 12 months

  2. Radiographic Bone Level [ Time Frame: Baseline ]
    Mean radiographic bone level at baseline

Biospecimen Retention:   Samples Without DNA
saliva and plaque biofilm

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Tae-Ju Oh, Clinical Professor, University of Michigan Identifier: NCT00933491     History of Changes
Other Study ID Numbers: 2008-03
First Posted: July 7, 2009    Key Record Dates
Results First Posted: November 4, 2015
Last Update Posted: November 4, 2015
Last Verified: October 2015

Keywords provided by Tae-Ju Oh, University of Michigan:

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