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

NCT04399161 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-22

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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.

Conditions

  • Cariostatic Agents
  • Mouthwashes

Interventions

DRUG

Chlorhexidine mouthwash

A commercially available Chlorhexidine mouth rinse (Hexidine- 0.2 percentage Chlorhexidine gluconate) containing 0.2 percentage chlorhexidine gluconate per 10 ml will be used. 7.5 ml of the concentrate diluted with equal amounts of water to make 15ml will be used for rinsing.

DRUG

Xylitol

Xylitol mouth rinse at 10 percentage concentration will be used. The mouth rinse will be prepared by dissolving 1.5 gm of xylitol powder in 15 ml of water.

DRUG

Probiotic

Probiotic mouth rinse will be prepared by using a commercially available probiotic product (Sporolac Plus powder- 1gm sachet containing not less than 1.5 billion cells of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Bacillus coagulans, Saccharomyces boulardii). Each sachet will be dissolved in 15 ml of water in a measuring cup and used as a mouth rinse.

Sponsors & Collaborators

  • Dr. Krupa NC

    lead OTHER

Principal Investigators

  • Krupa NC · JSS Academy of Higher Education & Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2017-12-20
Completion
2017-12-20

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399161 on ClinicalTrials.gov