Reducing Bacteria That Cause Tooth Decay

Phase 3

Completed

• Conditions: Caries, Dental; Cariostatic Agents
• Interventions: Drug: Iodine (Betadine); Biological: NaOCL

• Registration Number: NCT03062605
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-21
• Primary Completion: 2012-02-11
• Study Completion: 2012-02-17
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-23
• Results First Submitted: 2019-11-06
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Results First Posted: 2019-12-24
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment(TX)	Iodine (Betadine)	. Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute
Treatment(TX)	NaOCL	. Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute
Control (CT)	Iodine (Betadine)	. Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute. The CT group was a positive control. Both of these treatments were done only once at the baseline. The reminder of the three-month study was to obtain saliva samples at specific times to determining microbial levels.

Primary Outcome Measures

Name	Time	Method
Microbial Levels	Baseline, 12 weeks	The CRT® Bacteria (Ivoclar Vivadent) saliva sample test is done on culture media that is specific for S. mutans and Lactobacillus. After incubation for 3 days the colonies are compared to photographic standards.