Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Non-surgical Periodontal Therapy on Host Response and Microbiological Profile of Type 2 Diabetics With Periodontal Disease.
Brief Summary: Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for periodontitis and subsequently a two-way relationship between diabetes and periodontitis was proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque have been reported to be insulin antagonists that disturb binding of insulin to its receptors and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics promotes more pathogenic bacteria into the subgingival microenvironment making them more susceptible to chronic periodontitis. Studies however differ in the types of periodontal pathogens present in these pockets. At the same time, very few studies have quantified them. This study proposes to investigate the effect that non-surgical periodontal therapy (NSPT) has on the periodontal parameters, HbA1c levels, microbiological profile and CRP levels of T2D patients with chronic periodontitis as compared to oral hygiene education (OHE)alone.


Options:
A: 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
B: 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)
C: 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
D: 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

Answer: D