Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to determine if certain levels of proteins lead to inflammation
      of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This
      protein is found at higher levels in areas of inflammation. This type of study is called an
      experimental gingivitis study. It will involve stopping your routine oral health care for 21
      days. If you qualify, you will receive a full dental cleaning at the beginning and end of the
      study. Approximately 30 patients will participate in this study at the Michigan Center for
      Oral Health Research (MCOHR).
    

Detailed description: 
      Gingivitis is a specific oral infectious disease that affects approximately 50% of the adult
      population on an average of 3 to 4 teeth. Although dental plaque is the primary etiology of
      most periodontal diseases, patients are not equally susceptible and do not respond similarly
      to professional care. Therefore, assessing the future risk of patients for developing
      gingivitis with possible subsequent progression to chronic periodontitis may help the
      clinician in elaborating a more accurate and suitable treatment plan for the patients and a
      better assessment of their prognoses. In fact, the prevention of plaque-induced gingivitis is
      still considered the first step in the maintenance of periodontal health.

      Experimental gingivitis has been used widely to study the microbiology and the events that
      occur in the transition from a state of gingival health to inflammation. In a classical study
      by Löe and Theilade, periodontally healthy subjects were asked to cease all forms of oral
      hygiene for 3-4 weeks.

      Studies of the levels of proinflammatory biomarkers have been of increased interest for the
      past decades. Since changes in the levels of these salivary biomarkers occur prior to
      clinical signs of gingivitis, their measurements may provide a more objective, earlier and
      accurate assessment of gingival inflammatory changes compared to the traditional bleeding and
      plaque indices.

      Despite the clinical significance of gingivitis, little is know about the correlation between
      the levels of salivary biomarkers, the presence of periodontal pathogens and IL-1
      polymorphism, and how this affect their susceptibility to gingivitis. If IL-1 polymorphism is
      indeed associated with increased levels of pro-inflammatory cytokines expression and the
      presence of specific periodontal pathogens, then screening for this polymorphism will be a
      valuable and necessary tool. As periodontal treatments, such as scaling and root planing,
      have been shown to be successful at decreasing the levels of IL-1 in the gingival crevicular
      fluid, a more aggressive treatment regimen may be warranted when the patient is genotype
      positive. If biomarkers in saliva and plaque biofilm can serve as accurate predictors of
      gingivitis, the ability for early detection of disease in patients is enhanced.
      Pro-inflammatory salivary biomarkers, specific pathogenic bacteria and genotype aid in
      establishing more accurate diagnostic and prognostic parameters of periodontal diseases,
      compared to current parameters (e.g. probing pocket depth, clinical attachment loss...) that
      reflect the history rather than the present and future status of disease. As a consequence,
      intervention can be initiated prior to irreversible tissue breakdown and oral health care
      costs may be reduced. Research efforts in the future should be directed toward the
      establishment of an affordable and practical chairside salivary test.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve two groups: 15 subjects who are IL-1 genotype positive and 15
        subjects who are IL-1 genotype negative. Potential participants will be recruited at the
        University of Michigan. A screening process will be performed by the study personnel to all
        potential participants to determine eligibility according to the inclusion and exclusion
        criteria. The prevalence of IL-1 genotype positive patients has been shown to be related to
        the patients' ethnic group. In Caucasians, the prevalence was found to be approximately 34%
        in non smokers. On the other hand, only about 2.3% of Asians and 26% of Hispanics were
        found to be IL-1 genotype positive. In order to limit ethnic variations, subjects in our
        study will be limited only to Caucasians.
      
Biospecimen description: 
      plaque, saliva, and intraoral specimens
    
Keywords: healthy