Status:
COMPLETED
Diabetes and Periodontal Therapy Trial
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
University of Alabama at Birmingham
University of Minnesota
Conditions:
Chronic Periodontitis
Type 2 Diabetes
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
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 el...
Detailed Description
This study is a multicenter, randomized, controlled, single-masked, Phase III trial to determine if non-surgical periodontal therapy (scaling and root planing) is efficacious in reducing elevated glyc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT00997178
Start Date
October 1 2009
End Date
December 1 2012
Last Update
January 20 2014
Active Locations (8)
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1
Clinical Site: University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Clinical Site: University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
Core Laboratory: University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Coordinating Center: Stony Brook University-
Stony Brook, New York, United States, 11794-8036