Diabetes and Periodontal Therapy Trial
Completed · Phase 3
Conditions studied: Chronic Periodontitis, Type 2 Diabetes
In brief
The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. The secondary aims of the study are to: 1. evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2). 2. assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.
Key facts
- Study ID
- NCT00997178
- Run by
- Stony Brook University
- People needed
- 514
- Starts
- 2009-10-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-01-20
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 35 years of age
- Screening HbA1c value ≥ 7% and <9%
- Physician diagnosed type 2 diabetes of more than three months duration
- Currently under the care of a physician for diabetes management
- No change in diabetes-related medications during the three months prior to enrollment. Change is defined as any of the following: change in dose of any 1 hyperglycemic drug by more than two-fold, change in dose of insulin of more than 10%, addition or subtraction of an oral hyperglycemic agent or insulin.
- Consent to contact treating physician and obtain physician agreement to refrain from changing diabetes- related medications during DPTT participation unless overt symptoms develop (e.g. polydipsia, polyuria), HbA1c is 9.5% or higher
- Moderate to severe chronic periodontitis, defined as loss of clinical attachment and probing depth of ≥5 mm at two sites in the mouth in 2 or more quadrants
- No definitive periodontal treatment during the six months prior to enrollment
- Likely to have at least 16 natural teeth for the entire length of study
- Informed consent obtained and signed
- Ability and willingness to cooperate with the study protocol and attend all study visits over the next 9 months
- Willingness to avoid pregnancy during study participation
You may not qualify if…
- Self-reported serious concurrent disease that at the discretion of the referring physician limits life expectancy to less than 1 year.
- Emergency room visit or physician visit within the last 30 days because of hyperglycemia or diabetes complications.
- Chronic or continuous use (daily for more than 7 consecutive days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months, other than low dose aspirin (e.g. 75-325 mg/day).
- Receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs
- Chronic treatment with systemic antibiotics (antibiotics for > 7 consecutive days within 30 days of baseline visit).
- Currently receiving dialysis.
- At increased risk of bleeding complications from dental treatment, based on medical history.
- Requires Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections).
- Heavy alcohol consumption (on average > 2 drinks/day for women and > 3 drinks/day for men).
- Currently pregnant or considering becoming pregnant within the 6 month follow-up period
- Any other criteria that in the opinion of the investigator would preclude study completion or problems with compliance
Where it is running
- Clinical Site: University of Alabama at Birmingham — Birmingham, Alabama, United States
- Clinical Site: University of Minnesota — Minneapolis, Minnesota, United States
- Core Laboratory: University of Minnesota — Minneapolis, Minnesota, United States
- Coordinating Center: Stony Brook University- — Stony Brook, New York, United States
- Administrative Center/Study Chair's Office: Stony Brook University — Stony Brook, New York, United States
- Clinical Site: Stony Brook University — Stony Brook, New York, United States
- University of Texas, Health Sciences Center at Houston — Houston, Texas, United States
- Clinical Site: University of Texas Health Science Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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