Periodontal Treatment Response in Type II Diabetic Patients

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. This is a double-blinded, randomized study investigating the effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response to periodontal treatment in type II diabetic patients with periodontal disease. The investigators believe that using triclosan containing toothpaste during periodontal treatment will decrease the local inflammatory response and that this reduction will improve periodontal status and metabolic control.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Colgate Palmolive
• Treatments: Listerine; Polystyrene sulfonic acid; Sodium Fluoride; Triclosan

Criteria

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