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OpenTrials
Completed

NCT Number: NCT00933491

Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

About this study

OBJECTIVE:

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.

MATERIALS AND METHODS:

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus: A Feasibility Cohort Study

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2009
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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