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Reducing Bacteria That Cause Tooth Decay

Primary Purpose

Caries, Dental, Cariostatic Agents

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Iodine (Betadine)
NaOCL
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries, Dental

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Treatment(TX)

    Control (CT)

    Arm Description

    . 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

    . 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.

    Outcomes

    Primary Outcome Measures

    Microbial Levels
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2017
    Last Updated
    December 10, 2019
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03062605
    Brief Title
    Reducing Bacteria That Cause Tooth Decay
    Official Title
    Reducing Microbial Levels in High Caries Risk Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 21, 2011 (Actual)
    Primary Completion Date
    February 11, 2012 (Actual)
    Study Completion Date
    February 17, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Dental, Cariostatic Agents

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    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
    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
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment(TX)
    Arm Type
    Active Comparator
    Arm Description
    . 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
    Arm Title
    Control (CT)
    Arm Type
    Active Comparator
    Arm Description
    . 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Iodine (Betadine)
    Intervention Type
    Biological
    Intervention Name(s)
    NaOCL
    Other Intervention Name(s)
    Clorox
    Primary Outcome Measure Information:
    Title
    Microbial Levels
    Description
    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.
    Time Frame
    Baseline, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vladimir W. Spolsky, DMD, MPH
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Brailsford SR, Byren RW, Beighton D. Evaluation of new dip slide test for the quantification of mutans streptococci from saliva. Bericht 1998.
    Results Reference
    background
    PubMed Identifier
    285102
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12636318
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17633507
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12693825
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    4511175
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16352875
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19361723
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12013347
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18832827
    Citation
    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.
    Results Reference
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    Reducing Bacteria That Cause Tooth Decay

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