Periodontal Treatment Response in Type II Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Florida
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01881074
First received: June 14, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type II Diabetes
Periodontal Disease
Drug: Triclosan containing toothpaste
Drug: Non-triclosan containing toothpaste

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Clinical Periodontal Parameters [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The changes in clinical parameters(i.e. pocket depth, plaque, clinical attachment loss) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Clinical parameters will be assessed using a conventional periodontal probe and recorded in supporting software (Florida Probe).

  • Local Inflammatory Markers [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The changes in local inflammatory markers (i.e. cytokines, chemokines, metalloproteinases) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Local inflammatory markers in gingival crevicular fluid will be assayed in the laboratory.


Secondary Outcome Measures:
  • Glycemic Control [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The changes in glycemic control (i.e. HbA1C levels) during periodontal treatment from baseline to 3 months, 6 months and 12 months. Blood will be analyzed by the core lab facility at the University of Florida and Shands hospital and in the clinic/laboratory using a commercially available finger prick device and testing strips.

  • Systemic Inflammatory Markers [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The changes in systemic inflammatory markers (i.e. cytokines, chemokines, metalloproteinases) during periodontal treatment from baseline to 3 months, 6 months and 12 months of periodontal treatment. Inflammatory markers in venous blood will be assayed in the laboratory.


Estimated Enrollment: 68
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Name: Colgate Total
Placebo Comparator: 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.
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.
Other Name: Colgate

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881074

Contacts
Contact: Sandra Stuhr, BA 352-273-7911 sstuhr@dental.ufl.edu
Contact: Nicole L Ledger, BA 352-273-8364 nledger@dental.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Sandra Stuhr, BA    352-273-7911    sstuhr@dental.ufl.edu   
Contact: Nicole L Ledger, BA    352-273-8364    nledger@dental.ufl.edu   
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD         
Sponsors and Collaborators
University of Florida
Colgate Palmolive
Investigators
Principal Investigator: Luciana M Shaddox, DDS, MS, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01881074     History of Changes
Other Study ID Numbers: 287-2011, CRO-2011-PERIO-01-FP
Study First Received: June 14, 2013
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Type II Diabetes
Periodontal Disease
Periodontitis
Gum Disease
Gingivitis
Triclosan
Inflammatory Markers
Immune Response

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Periodontal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 26, 2014