Reducing Bacteria That Cause Tooth Decay
Condition: Caries, Dental; Cariostatic Agents
MeSH terms: Dental Caries
Intervention: Iodine (Betadine); NaOCL
Intervention MeSH terms: Povidone-Iodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to one of two treatment groups and continued in parallel for the three-month duration of the study.
Masking: Single (Investigator)
Masking description: This was a single blind study. The participants knew which one time treatment they were receiving, but the person doing the saliva sampling and testing did not know which treatment the participant was assigned
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on
      reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step
      mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs
      better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both
      treatment groups is done only once at the beginning of the study after the initial saliva
      samples are taken, and before a detailed examination of the teeth and gums. It is
      hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have
      significantly lower microbial counts than the control group (Povidone iodine) because the
      NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in
      decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken
      from participants at baseline, one week, one month, two months and three months. The samples
      are tested by two commercial methods for determining microbial counts. The CariScreen Test is
      a rapid bioluminescence assay that quantitates the total number of all of the organisms
      present. The CRT test requires a culture media that is specific for the two germs (S. mutans
      and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read
      after three days of incubation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  being over 20 years of age;

          -  having at least one obviously cavitated tooth;

          -  refraining from smoking, brushing the teeth and using a mouthwash the day of the
             bacterial sampling;

          -  refraining from using a commercial mouth rinse during the three months of the study;

          -  having any two of the following risk factors in the Caries Management by Risk
             Assessment (CAMBRA) protocol which qualifies as a high caries risk.

        The high caries risk factors included:

          -  receiving fillings within the past three years;

          -  snacking frequently between meals;

          -  presenting with hyposalivation due to medication, radiation or systemic conditions;

          -  visual presence of heavy plaque accumulation;

          -  and a minimum of 20 natural teeth.

        Exclusion Criteria:

          -  using a systemic antibiotic within the past three months;

          -  currently receiving dental treatment or planning to receive treatment within the next
             three months (emergency treatment allowed);

          -  being pregnant or nursing;

          -  any thyroid disease or sensitivity to iodine;

          -  the use of a commercially available mouth rinse the day of the screening examination;

          -  smoking, brushing the teeth and using a mouth rinse the day of the bacterial sampling;

          -  not being able to make morning examinations.