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Phase 3 Completed N=60 Randomized Double-blind Prevention

Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk

Cariostatic Agents · Mouthwashes
Source: ClinicalTrials.gov NCT04399161 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Change in Streptococcus Mutans Levels in Dental Plaque — 3.11; 0.93; 1.91; 2.23 log10CFU/g — p=0.123
◆ Published Evidence
Emerging
18citations · ~5 / year
Antimicrobial efficacy of Xylitol, Probiotic and Chlorhexidine mouth rinses among children and elderly population at high risk for dental caries - A Randomized Controlled Trial.
Journal of preventive medicine and hygiene · 2022 · Open access · Likely link

Summary

Dental caries is a localized, post eruptive pathological process involving softening of the hard tooth tissue and proceeding to the formation of cavity. It results from accumulation of plaque on the surface of the teeth and biochemical activities of complex microorganisms. Streptococcus mutans is one of the main pathogens of dental caries. Although brushing has the potential to maintain adequate levels of oral hygiene, studies demonstrate that such methods are not being employed sufficiently. The need for additional help in controlling bacterial plaque provides the rationale for patients using mouth rinses as adjuncts. Chlorhexidine although considered the gold standard, its side effects due to prolonged use such as staining of teeth, dry mouth, altered taste sensation, mouth/ throat irritation, etc indicates the need for alternatives. Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Probiotic technology represents a breakthrough approach to maintaining oral health by utilizing natural beneficial bacteria commonly found in healthy mouths to provide a natural defense against those bacteria thought to be harmful to teeth and gums. The advantages of using a probiotic mouth rinse are that it contains friendly microbes, there is no issue of antibiotic resistance, and there are no known/proven toxicities caused due to their use. Xylitol is a non-sugar sweetener permitted for use in foods. Xylitol is a naturally occurring non-cariogenic sugar substitute that cannot be metabolized by oral bacteria. This possesses various properties favorable for caries prevention.It acts by forming of loosely attached biofilms on the tooth surfaces that can be easily removed. Although many studies have evaluated the effects of xylitol chewing gum on caries prevention, there are very few examining the effect of xylitol mouth rinse on oral Streptococcus mutans. Hence xylitol mouth rinse may be introduced as a possible alternative. Antimicrobial efficacies of probiotics and xylitol mouth rinses have not been compared till date. Also their effects on the young and elderly population have not been compared. Hence the purpose of the study is to compare the antimicrobial efficacies of probiotic & xylitol mouth rinses with that of chlorhexidine in children and elderly population.

Linked Publications

  • Antimicrobial efficacy of Xylitol, Probiotic and Chlorhexidine mouth rinses among children and elderly population at high risk for dental caries - A Randomized Controlled Trial.
    Journal of preventive medicine and hygiene · 2022 · 18 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Streptococcus Mutans Levels in Dental Plaque
3.11; 0.93; 1.91; 2.23; 1.39; 1.61 0.123

Eligibility Criteria

Inclusion Criteria

  • Children aged 5-12 yrs at high risk for caries.
  • Elderly citizens (above 60 yrs) at high risk for caries.
  • Those willing to participate in the study and consented.
  • Not under antimicrobial therapy or used probiotic products during past 1 month.

Exclusion Criteria

  • Using mouth rinse routinely.
  • Undergoing any dental treatment during the study period.
  • Not able to brush their teeth and rinse on their own.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04399161) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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