Periodontal Treatment Response in Type II Diabetic Patients
Condition: Type II Diabetes; Periodontal Disease
MeSH terms: Periodontal Diseases; Diabetes Mellitus, Type 2
Study type: Observational

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.
    

Intervention name(s): Triclosan containing toothpaste; Non-triclosan containing toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Colgate Total; Colgate
Intervention MeSH terms: Listerine; Triclosan; Sodium Fluoride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type II diabetic patients with periodontal disease requiring periodontal treatment.
      
Biospecimen description: 
      blood, gingival crevicular fluid, and saliva
    
Keywords: Type II Diabetes; Periodontal Disease; Periodontitis; Gum Disease; Gingivitis; Triclosan; Inflammatory Markers; Immune Response