N/A
N=32
Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00933491 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Radiographic Bone Level — 2.69; 2.54 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Bone Level |
2.59; 2.71 | — |
| PRIMARY Radiographic Bone Level |
2.59; 2.71 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00933491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.