Diabetes and Periodontal Therapy Trial (DPTT)

Inclusion Criteria:

• 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 Criteria:

• 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