Diabetes
Conditions
Keywords
healthy
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.
Interventions
None listed
Sponsors
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Level | 12 months | Mean radiographic bone level at 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetic Type II Diabetes | 14 |
| Control Non-diabetics | 18 |
| Total | 32 |
Baseline characteristics
| Characteristic | Control | Diabetic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 14 Participants | 32 Participants |
| Age, Continuous | 64 years | 65 years | 64.5 years |
| Region of Enrollment United States | 18 participants | 14 participants | 32 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 18 |
| serious Total, serious adverse events | 0 / 14 | 0 / 18 |
Outcome results
Primary
Radiographic Bone Level
Mean radiographic bone level at 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | Radiographic Bone Level | 2.69 mm | Standard Deviation 0.17 |
| Control | Radiographic Bone Level | 2.54 mm | Standard Deviation 0.15 |
Primary
Radiographic Bone Level
Mean radiographic bone level at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | Radiographic Bone Level | 2.59 mm | Standard Deviation 0.15 |
| Control | Radiographic Bone Level | 2.71 mm | Standard Deviation 0.14 |