Reducing Bacteria That Cause Tooth Decay

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caries, Dental Cariostatic Agents Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iodine (Betadine)

Drug

NaOCL

Biological

Other names: Clorox

Primary outcomes

Microbial Levels

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Reducing Microbial Levels in High Caries Risk Adults

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 23, 2017
Registry last updated: Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed