Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933491
• Other study ID #: 2008-03
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2009
• Last updated: October 7, 2015
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Bone Level	Mean radiographic bone level at 12 months	12 months	No
Primary	Radiographic Bone Level	Mean radiographic bone level at baseline	Baseline	No

External Links

•   University of Michigan Center for Oral Health Research
•   University of Michigan Clinical Research Database homepage