Periodontal Treatment Response in Type II Diabetic Patients

NCT ID: NCT01881074

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Type II Diabetes; Periodontal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Triclosan containing toothpaste

Patients with type II diabetes will receive triclosan containing toothpaste and will be asked to brush their teeth using only this toothpaste for the duration of the study (12 months). Patients will be asked to return for an oral exam, dental cleaning and sample collection for up to 12 months following their baseline appointment.

Triclosan containing toothpaste

Intervention Type: DRUG

Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the triclosan containing toothpaste provided to them. Additional tubes of triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.

Non-triclosan containing toothpaste

Patients with type II diabetes will receive non-triclosan containing toothpaste and will be asked to brush their teeth using only this toothpaste for the duration of the study (12 months). Patients will be asked to return for an oral exam, dental cleaning and sample collection for up to 12 months following their baseline appointment.

Non-triclosan containing toothpaste

Intervention Type: DRUG

Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the non-triclosan containing toothpaste (i.e. placebo) provided to them. Additional tubes of non-triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.

Interventions

Triclosan containing toothpaste

Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the triclosan containing toothpaste provided to them. Additional tubes of triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.

Intervention Type: DRUG

Non-triclosan containing toothpaste

Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the non-triclosan containing toothpaste (i.e. placebo) provided to them. Additional tubes of non-triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.

Intervention Type: DRUG

Other Intervention Names

Colgate Total; Colgate

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana M Shaddox, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

CRO-2011-PERIO-01-FP

Identifier Type: OTHER

Identifier Source: secondary_id

287-2011

Identifier Type: -

Identifier Source: org_study_id