CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Chlorhexidine mouthwash +2 moredrug
Likely dose
Chlorhexidine mouthwash 10 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04399161
NCT04399161Phase 3Completed

Antimicrobial Efficacy of Xylitol, Probiotic and Chlorhexidine Mouth Rinses Among Children and Elderly Population at High Risk for Dental Caries - A Double Blind Randomized Controlled Trial

Dr. Krupa NC·interventional·Posted May 22, 2020·Updated Jul 22, 2020

In Brief

A Phase 3 clinical trial evaluating Chlorhexidine mouthwash, Xylitol, and 1 other intervention for Cariostatic Agents and Mouthwashes. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 22, 2020
Enrollment StartFeb 15, 2017
Primary CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.1 years ago

Interventions

Chlorhexidine mouthwashdrug

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.

Xylitoldrug

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.

Probioticdrug

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.