Periodontal Treatment Response in Type II Diabetic Patients

Many studies have shown a relationship between chronic inflammatory periodontal diseases and
diabetes, in which both diseases influence the other. Research studies have shown that
controlling inflammation of the gums can improve the level of metabolic control (i.e. blood
glucose levels) in patients with diabetes. However, it is still not clear which periodontal
treatment approach would best maintain the control of inflammation of diabetic patients.
Triclosan has anti-plaque and anti-inflammatory properties and decreases gum inflammation.
The purpose of this study is to 1) determine the effects of triclosan containing toothpaste
on gum inflammation in type II diabetic patients with periodontal disease, and 2) to evaluate
whether type II diabetic patients will show improvement in periodontal status and blood
glucose following periodontal treatment with and without the use of a triclosan containing
toothpaste.

Patients with type II diabetes that meet the study criteria will be randomly assigned either
triclosan containing toothpaste or placebo toothpaste. Dental cleanings and oral exams will
be performed at baseline, 6 weeks, 3, 6, 9 and 12 months, and samples will be collected at
baseline, 3, 6 and 12 months. Samples that may be collected include blood, plaque, gingival
crevicular fluid, saliva and plaque. Women may also be asked to complete a pregnancy test.
Photographs and x-rays of the patients mouth/teeth may be taken, but is not a requirement.

The samples collected will be used to assess the effect of triclosan containing toothpaste on
glycemic control and local and systemic inflammatory mediators during the course of
periodontal treatment.

Inclusion Criteria:

- Subject males or females 18 to 70 years old

- Subject able and willing to follow study procedures and instructions

- Subject read, understood and signed an informed consent form

- Subject diagnosed with type II diabetes

- Currently under standard treatment and physicians care for diabetes control

- Standard diabetes medication has not changed in the last 3 months

- HbA1c levels of ≥ 6.5% determined upon medical record review within the last 6 months
(if HbA1c value not available in medical record or if patient is new, the first study
visit value will determine if patient may continue in the study)

Exclusion Criteria:

- Subject with concomitant periodontal therapy 6 months prior to enrollment

- Subject with orthodontic appliances

- Subject chronically treated (i.e., two weeks or more) with any medication known to
affect inflammation or periodontal status or (e.g.phenytoin, cyclosporine, Coumadin or
steroids) within one month of the first examination*

- Subject currently smoke or who report smoking within one year of first examination ≥
10 cigarettes/day

- Subject treated with antibiotics within 3 months prior to enrollment

- Subject necessitating antibiotic prophylaxis

- Female subject who report being pregnant or lactating at first appointment

- Subject uses hormonal contraceptives but started method less than 30 days prior to the
first examination

- Subject with active infectious diseases (hepatitis, human immunodeficiency virus or
Tuberculosis) or subject is immunocompromised as determined by the Investigator

- Subjects has a medical condition which precludes not eating/drinking for approximately
8 hours

- Subject has serious diabetic complications such as macrovascular diseases or kidney or
liver failure

- Subjects who have a known allergy to oral care products or ingredients in oral care
products