Clinical trial NCT01881074: Periodontal Treatment Response in Type II Diabetic Patients
Official title: The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes
Periodontal Disease
Keywords: Type II Diabetes
Periodontal Disease
Periodontitis
Gum Disease
Gingivitis
Triclosan
Inflammatory Markers
Immune Response
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2013-06-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type II diabetic patients with periodontal disease requiring periodontal treatment.

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Clinical Periodontal Parameters
timeFrame: Baseline, 3, 6 and 12 months
measure: Local Inflammatory Markers
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Glycemic Control
timeFrame: Baseline, 3, 6 and 12 months
measure: Systemic Inflammatory Markers
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Luciana M Shaddox, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: