Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

NCT00933491 | Completed Results

• 1 other identifier: 2008-03
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

healthy

Outcome Measures

Primary Outcomes (2)

• Radiographic Bone Level

  Mean radiographic bone level at 12 months

  12 months

• Radiographic Bone Level

  Mean radiographic bone level at baseline

  Baseline

Study Arms (2)

Diabetic

Type II Diabetes

Control

Non-diabetics

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type II diabetics and non diabetics with dental implants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• Tatarakis N, Kinney JS, Inglehart M, Braun TM, Shelburne C, Lang NP, Giannobile WV, Oh TJ. Clinical, microbiological, and salivary biomarker profiles of dental implant patients with type 2 diabetes. Clin Oral Implants Res. 2014 Jul;25(7):803-12. doi: 10.1111/clr.12139. Epub 2013 Feb 27.

  PMID: 23445216 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva and plaque biofilm

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Tae-Ju Oh
• Organization: University of Michigan

taejuoh@umich.edu

734-647-3320

Study Officials

• Tae-Ju Oh, DDS, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 4, 2015
• Results First Posted: November 4, 2015

Record last verified: 2015-10

Locations

US (1)