Reducing Bacteria That Cause Tooth Decay

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT03062605
• Collaborator: (none)
• Enrollment: 48
• Arms: 2
• Actual Duration (Months): 8.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental; Cariostatic Agents	Drug: Iodine (Betadine); Biological: NaOCL	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 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.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: Feb 11, 2012
• Actual Study Completion Date: Feb 17, 2012

Arms and Interventions

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 Names: 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)

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Vladimir W. Spolsky, DMD, MPH, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

• Brailsford SR, Byren RW, Beighton D. Evaluation of new dip slide test for the quantification of mutans streptococci from saliva. Bericht 1998.
• 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.
• 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. Review.
• Dye BA, Tan S, Smith V, Lewis BG, Barker LK, Thornton-Evans G, Eke PI, Beltrán-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.
• 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. Review.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Review.

• Responsible Party: University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03062605
• Other Study ID Numbers: 20102774
• First Posted: Feb 23, 2017
• Last Update Posted: Dec 24, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dental Caries; Povidone-Iodine

Study Results

Participant Flow

Arm/Group Title	Treatment(TX)	Control (CT)
Arm/Group 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 Iodine (Betadine) NaOCL	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. Iodine (Betadine)
Period Title: Overall Study
STARTED	25	23
COMPLETED	14	13
NOT COMPLETED	11	10

Baseline Characteristics

Arm/Group Title	Treatment(TX)	Control (CT)	Total
Arm/Group 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 Iodine (Betadine) NaOCL	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. Iodine (Betadine)	Total of all reporting groups
Overall Participants	25	23	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.4 (10.2)	38.2 (6.6)	39.4 (8.6)
Sex: Female, Male (Count of Participants)
Female	15 60%	18 78.3%	33 68.8%
Male	10 40%	5 21.7%	15 31.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	23 100%	48 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number analyzed includes participants retained in the study for whom CRT results were available

Arm/Group Title	Treatment(TX)	Control (CT)
Arm/Group 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 Iodine (Betadine) NaOCL	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. Iodine (Betadine)
Measure Participants	25	23
Strep Mutans >10^5 at Baseline	11 44%	7 30.4%
Lactobacillus >10^5 at Baseline	15 60%	15 65.2%
Strep Mutans >10^5 at 12 Weeks	2 8%	5 21.7%
Lactobacillus >10^5 at 12 Weeks	5 20%	4 17.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment(TX)
	Comments	Strep Mutans, Baseline-12 Weeks
	Type of Statistical Test	Other
	Comments	Inequality test
Statistical Test of Hypothesis	p-Value	0.35
	Comments	Significant at p < 0.05
	Method	McNemar
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control (CT)
	Comments	Strep Mutans, Baseline-12 Weeks
	Type of Statistical Test	Other
	Comments	Inequality test
Statistical Test of Hypothesis	p-Value	0.29
	Comments	Significant at p<0.05
	Method	McNemar
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Treatment(TX)
	Comments	Lactobacillus, Baseline-12 Weeks
	Type of Statistical Test	Other
	Comments	Inequality test
Statistical Test of Hypothesis	p-Value	0.09
	Comments	Significant at p < 0.05
	Method	McNemar
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Control (CT)
	Comments	Lactobacillus, Baseline-12 Weeks
	Type of Statistical Test	Other
	Comments	Inequality test
Statistical Test of Hypothesis	p-Value	0.13
	Comments	Significant at p < 0.05
	Method	McNemar
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Treatment(TX)		Control (CT)
Arm/Group 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 Iodine (Betadine) NaOCL		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. Iodine (Betadine)
All Cause Mortality
	Treatment(TX)		Control (CT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment(TX)		Control (CT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Treatment(TX)		Control (CT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.