Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS
Brief Summary: Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American population, prevalence rates may be up to 50%. Contributing factors such as poor education, low household income, language barriers and restricted access to medical services may increase this prevalence. The association between periodontal disease and diabetes has been well documented; however, interventional studies have resulted in conflicting conclusions on improvements in glycemic control following periodontal therapy.

Diabetes and periodontal disease share common pathways in pathogenesis, such as their polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the investigators, propose this randomized controlled trial designed to elucidate how treatment of periodontal disease can be used for preventive and therapeutic purposes in a diabetic population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is that the Mexican-American T2DM population in Texas is at risk for an increased presence and severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms; furthermore we suggest that providing non-surgical periodontal therapy to this group will decrease the bacterial load associated with disease and as a consequence, will improve glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors associated with the presence of periodontal disease and to understand how the treatment of periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2 diabetic population.


Options:
A: Inclusion Criteria:

* Type 2 Diabetes Mellitus patients whose diagnosis had been established (World Health Organization, 1999) and were on regular follow-ups for a minimum of 6 months.
* Patients should have at least 12 teeth present
* Patients with 2 or more interproximal sites (not on same tooth) with probing pocket depths of 5mm or more and 2 or more interproximal sites (not on same tooth)of probing attachment loss of 4mm or more which bled on probing.

Exclusion Criteria:

* Patients who had history of systemic antibiotic usage over the previous 4 months
* Patients who were pregnant
* Patients who had received non-surgical periodontal treatment within the past 6 months
* Patients who had received surgical periodontal treatment within the past 12 months
* Patients who were smokers
* Patients with a history of stroke or an acute cardiovascular event over the previous 12 months.
* Patients who had their diabetic medication changed during the course of the study
B: Inclusion Criteria:

* Type 2 diabetes for at least one year
* periodontitis
* HbA1c \> 7%

Exclusion Criteria:

* Periodontal treatment in the last 6 months
* antibiotics in the last 3 months
* tobacco smoking
* pregnancy
C: 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
D: Inclusion Criteria:

* At least 18 years old
* Diagnosed type 2 diabetes mellitus
* Existence of moderate to severe periodontitis as defined by the American Academy of Periodontology
* In good general health - able to undergo the proposed therapy without compromise to existing health
* Demonstrated ability to read and understand written Spanish or English without the aid of ad-hoc interpretation by a third party
* Demonstrated ability to understand the proposed therapy and possible outcome
* Demonstrated willingness to comply with all protocol requirements as outlined in the informed consent document
* Willingness/ability to sign an informed consent document for their own inclusion in the study
* Hispanic origin as confirmed by patient records

Exclusion Criteria:

* Pregnancy at the time of enrollment (Pregnancy test is required for female study participants of child-bearing potential.)
* Use of antibiotics within last 3 months
* Immunocompromised health status
* Other medical conditions that represent a threat to life
* Osteoporosis
* Biphosphonates, corticosteroids or behavior alteration medications
* Historical abuse of alcohol or drugs
* Use of cigarettes/tobacco products within the past 12 months
* Mental diseases
* Any other oral pathology that compromise the patient's medical status
* Diagnosed type 1 diabetes mellitus (Information will be obtained from the medical records)

Answer: D