Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 80 of 1200 for:    tooth decay

Reducing Bacteria That Cause Tooth Decay

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03062605
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Vladimir W. Spolsky, DMD, MPH, 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.

Condition or disease Intervention/treatment Phase
Caries, Dental Cariostatic Agents Drug: Iodine (Betadine) Biological: NaOCL Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Primary Purpose: Prevention
Official Title: Reducing Microbial Levels in High Caries Risk Adults
Actual Study Start Date : May 21, 2011
Actual Primary Completion Date : February 11, 2012
Actual Study Completion Date : February 17, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Iodine

Arm Intervention/treatment
Active Comparator: Treatment(TX)
. 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
Drug: Iodine (Betadine)
Biological: NaOCL
Other Name: Clorox

Active Comparator: Control (CT)
. 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.
Drug: Iodine (Betadine)



Primary Outcome Measures :
  1. Quantities of Microbes [ Time Frame: 3 days ]
    The CRT 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. Caries Screen is done after the saliva sample is placed in a meter that reads the number of microbes present.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062605


Sponsors and Collaborators
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Vladimir W. Spolsky, DMD, MPH University of California, Los Angeles

Publications:
Brailsford SR, Byren RW, Beighton D. Evaluation of new dip slide test for the quantification of mutans streptococci from saliva. Bericht 1998.
Hallett KB, O'Rourke PK. Oral Biofilm activity, culture testing and caries experience in school children. International Journal of Paediatric Dentistry. 2009;19(Suppl. 2):4.

Layout table for additonal information
Responsible Party: Vladimir W. Spolsky, DMD, MPH, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03062605     History of Changes
Other Study ID Numbers: 20102774
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Iodine
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs