The Microbiology of Caries Resistance
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to investigate the bacterial composition of plaque and
      saliva located in the mouth and associate that with risk factors that cause cavities.
    

Detailed description: 
      Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked
      to fill out a study registration form and an oral habits/medical history form. They will be
      asked to sign an Informed Consent. The subject will then have their teeth and gums examined.
      At this visit, the investigator will assess whether or not the subject is a good candidate
      for the study. During the phone interview each subject was asked not to brush or floss their
      teeth and not to eat or drink anything other than water for 8 hours prior to the
      pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples
      will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline).
      If not, they will be asked to return to the clinic for another visit and asked not to brush
      or floss their teeth and not to eat or drink anything other than water 8 hours prior to that
      appointment. This visit will then be consider Visit 1 (Baseline).

      Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They
      will have their teeth and gums examined. Saliva and plaque will be collected. Each subject
      will be given a toothbrush and toothpaste and instructed to not use any other dental
      products. This will be considered the "washout" period.

      Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental
      history will be reviewed and they will have their teeth examined. Saliva and plaque will be
      collected at this visit. The subjects will then be randomly assigned (by chance, like the
      flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to
      the group that will use a marketed arginine containing toothpaste. The subject will also be
      instructed not to brush or floss their teeth or eat or drink anything other than water for 8
      hours prior to your next appointment.

      Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or
      drink anything other than water 8 hours prior to these visits. Saliva and plaque will be
      collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At
      this time participation in this research study will end and they will be instructed to return
      to their regular oral hygiene regiments.
    

Intervention name(s): Caries Free; Caries Active; Caries Free - Placebo; Caries Active - Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.; Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.; Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.; Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Plaque, Saliva, Cavities