At a glance
ClinicalIndex Comparison Record- ✓Age over 20 years
- ✓At least one obviously cavitated tooth
- ✓High caries risk defined by ≥2 CAMBRA risk factors
- ✓Minimum 20 natural teeth
- ✕Systemic antibiotic use within past 3 months
- ✕Dental treatment planned or ongoing (except emergency)
- ✕Pregnancy or nursing
- ✕Thyroid disease or iodine sensitivity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Reducing Microbial Levels in High Caries Risk Adults
In Brief
A Phase 3 clinical trial evaluating Iodine (Betadine) and NaOCL for Caries, Dental and Cariostatic Agents. Completed, enrolled 48 participants.
Detailed 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.