NCT04399161: AEXPC

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

Completed Phase 2, PHASE3 Results posted Last updated 22 July 2020

What this trial tests

Phase 2, PHASE3 trial testing Chlorhexidine mouthwash in Cariostatic Agents in 60 participants. Completed in 20 December 2017.

Timeline

15 February 2017

Primary endpoint
20 December 2017

20 December 2017

Quick facts

Lead sponsor	Dr. Krupa NC
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	60
Start date	15 February 2017
Primary completion	20 December 2017
Estimated completion	20 December 2017
Sites	1 location across India

Drugs / interventions tested

• Chlorhexidine mouthwash — full drug profile →
• Xylitol — full drug profile →
• Probiotic

Conditions studied

• Cariostatic Agents — all drugs for Cariostatic Agents →
• Mouthwashes — all drugs for Mouthwashes →

Sponsor

Dr. Krupa NC

Who can join

Adults 5 to 90, any sex, with Cariostatic Agents or Mouthwashes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Streptococcus Mutans Levels in Dental Plaque Primary · Assessment of change in Streptococcus mutans levels 14 days after intervention

Change in Streptococcus mutans levels in dental plaque after using mouth rinses for 14 days to determine their antimicrobial efficacy.

Children (5-12 years)

Group	Value	95% CI
Group A (Chlorhexidine Mouthrinse)	3.11	± 2.32
Group B (Xylitol Mouth Rinse)	0.93	± 0.86
Group C (Probiotic Mouth Rinse)	1.91	± 1.67

Elderly (above 60 years)

Group	Value	95% CI
Group A (Chlorhexidine Mouthrinse)	2.23	± 1.08
Group B (Xylitol Mouth Rinse)	1.39	± 0.81
Group C (Probiotic Mouth Rinse)	1.61	± 0.92

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A (Chlorhexidine Mouthrinse)

Serious: 0/20 (0%)

Deaths: 0/20

Group B (Xylitol Mouth Rinse)

Serious: 0/20 (0%)

Deaths: 0/20

Group C (Probiotic Mouth Rinse)

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Group A (Chlorhexidine Mou…	Group B (Xylitol Mouth Rin…	Group C (Probiotic Mouth R…
irritation of oral mucosa (burning sensation in the mouth and tongue)	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT04399161 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antimicrobial efficacy of Xylitol, Probiotic and Chlorhexidine mouth rinses among children and elderly population at high risk for dental caries - A Randomized Controlled Trial.
   Krupa NC, Thippeswamy HM, Chandrashekar BR. · · 2022 · cited 14× · PMID 35968060 · DOI 10.15167/2421-4248/jpmh2022.63.2.1772