Clinical trial NCT00933491: Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus
Official title: Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus: A Feasibility Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type II diabetics and non diabetics with dental implants

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic Bone Level
timeFrame: 12 months
measure: Radiographic Bone Level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tae-Ju Oh, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.