Reducing Bacteria That Cause Tooth Decay

Caries, Dental Clinical Trial

Official title:

Reducing Microbial Levels in High Caries Risk Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062605
• Other study ID #: 20102774
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2011
• Est. completion date: February 17, 2012

Study information

• Verified date: December 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 17, 2012
• Est. primary completion date: February 11, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries, Dental
• Cariostatic Agents
• Dental Caries

Intervention

Drug:
• Iodine (Betadine)

Biological:
• NaOCL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

References & Publications (11)

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. — View 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. Review. — View Citation

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. — View 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. Review. — View 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.

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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 weeks