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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic | Type II Diabetes | ||
| Control | Non-diabetics |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Bone Level | Mean radiographic bone level at 12 months | 12 months |
| Radiographic Bone Level | Mean radiographic bone level at baseline | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Type II diabetics and non diabetics with dental implants
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| Name | Affiliation | Role |
|---|---|---|
| Tae-Ju Oh, DDS, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Center for Oral Health Research | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23445216 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic | Type II Diabetes |
| FG001 | Control | Non-diabetics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic | Type II Diabetes |
| BG001 | Control | Non-diabetics |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiographic Bone Level | Mean radiographic bone level at 12 months | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
2 years
We monitored for adverse events from subject recruitment phase to completion of the study which took two years (2008-2010).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic | Type II Diabetes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tae-Ju Oh | University of Michigan | 734-647-3320 | taejuoh@umich.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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saliva and plaque biofilm
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Radiographic Bone Level | Mean radiographic bone level at baseline | Posted | Mean | Standard Deviation | mm | Baseline |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Control | Non-diabetics | 0 | 18 | 0 | 18 |
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