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Reducing Bacteria That Cause Tooth Decay

NCT ID: NCT03062605

Last Updated: 2019-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-21

Study Completion Date

2012-02-17

Brief Summary

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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

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Conditions

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Caries, Dental Cariostatic Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned to one of two treatment groups and continued in parallel for the three-month duration of the study.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Iodine (Betadine)

Intervention Type DRUG

NaOCL

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

Iodine (Betadine)

Intervention Type DRUG

Interventions

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Iodine (Betadine)

Intervention Type DRUG

NaOCL

Intervention Type BIOLOGICAL

Other Intervention Names

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Clorox

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir W. Spolsky, DMD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

References

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Brailsford SR, Byren RW, Beighton D. Evaluation of new dip slide test for the quantification of mutans streptococci from saliva. Bericht 1998.

Reference Type BACKGROUND

Caufield PW, Gibbons RJ. Suppression of Streptococcus mutans in the mouths of humans by a dental prophylaxis and topically-applied iodine. J Dent Res. 1979 Apr;58(4):1317-26. doi: 10.1177/00220345790580040301.

Reference Type BACKGROUND
PMID: 285102 (View on PubMed)

DenBesten P, Berkowitz R. Early childhood caries: an overview with reference to our experience in California. J Calif Dent Assoc. 2003 Feb;31(2):139-43.

Reference Type BACKGROUND
PMID: 12636318 (View on PubMed)

Dye BA, Tan S, Smith V, Lewis BG, Barker LK, Thornton-Evans G, Eke PI, Beltran-Aguilar ED, Horowitz AM, Li CH. Trends in oral health status: United States, 1988-1994 and 1999-2004. Vital Health Stat 11. 2007 Apr;(248):1-92.

Reference Type BACKGROUND
PMID: 17633507 (View on PubMed)

Featherstone JD, Adair SM, Anderson MH, Berkowitz RJ, Bird WF, Crall JJ, Den Besten PK, Donly KJ, Glassman P, Milgrom P, Roth JR, Snow R, Stewart RE. Caries management by risk assessment: consensus statement, April 2002. J Calif Dent Assoc. 2003 Mar;31(3):257-69. No abstract available.

Reference Type BACKGROUND
PMID: 12693825 (View on PubMed)

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.

Reference Type BACKGROUND

Lenox JA, Kopczyk RA. A clinical system for scoring a patient's oral hygiene performance. J Am Dent Assoc. 1973 Apr;86(4):849-52. doi: 10.14219/jada.archive.1973.0178. No abstract available.

Reference Type BACKGROUND
PMID: 4511175 (View on PubMed)

Matsumoto Y, Sugihara N, Koseki M, Maki Y. A rapid and quantitative detection system for Streptococcus mutans in saliva using monoclonal antibodies. Caries Res. 2006;40(1):15-9. doi: 10.1159/000088900.

Reference Type BACKGROUND
PMID: 16352875 (View on PubMed)

Pellegrini P, Sauerwein R, Finlayson T, McLeod J, Covell DA Jr, Maier T, Machida CA. Plaque retention by self-ligating vs elastomeric orthodontic brackets: quantitative comparison of oral bacteria and detection with adenosine triphosphate-driven bioluminescence. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):426.e1-9; discussion 426-7. doi: 10.1016/j.ajodo.2008.12.002.

Reference Type BACKGROUND
PMID: 19361723 (View on PubMed)

Slots J, Jorgensen MG. Effective, safe, practical and affordable periodontal antimicrobial therapy: where are we going, and are we there yet? Periodontol 2000. 2002;28:298-312. doi: 10.1034/j.1600-0757.2002.2801123.x.

Reference Type BACKGROUND
PMID: 12013347 (View on PubMed)

Takahashi N, Nyvad B. Caries ecology revisited: microbial dynamics and the caries process. Caries Res. 2008;42(6):409-18. doi: 10.1159/000159604. Epub 2008 Oct 3.

Reference Type BACKGROUND
PMID: 18832827 (View on PubMed)

Other Identifiers

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20102774

Identifier Type: -

Identifier Source: org_study_id