Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00933491|
Recruitment Status : Completed
First Posted : July 7, 2009
Results First Posted : November 4, 2015
Last Update Posted : November 4, 2015
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|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
- Radiographic Bone Level [ Time Frame: 12 months ]Mean radiographic bone level at 12 months
- Radiographic Bone Level [ Time Frame: Baseline ]Mean radiographic bone level at baseline
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933491
|United States, Michigan|
|Michigan Center for Oral Health Research|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Tae-Ju Oh, DDS, MS||University of Michigan|