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

NCT04399161 | Completed Phase 2 Results

• 1 other identifier: JSSDCH/Ethical/05/2016-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Streptococcus mutans; Chlorhexidine; Xylitol; Probiotic

Outcome Measures

Primary Outcomes (1)

• Change in Streptococcus Mutans Levels in Dental Plaque

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

  Assessment of change in Streptococcus mutans levels 14 days after intervention

Study Arms (2)

Child Participants

EXPERIMENTAL

Residential school children aged 5-12 yrs at high risk for caries. A total of 36 children will be recruited for the study and randomly divided into 3 groups with 12 participants per group.The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.

Drug: Chlorhexidine mouthwash; Drug: Xylitol; Drug: Probiotic

Elderly Participants

EXPERIMENTAL

Elderly citizens (above 60 yrs) at high risk for caries. A total of 36 elderly will be chosen based on eligibility criteria and randomly divided into 3 groups with 12 participants per group. The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.

Drug: Chlorhexidine mouthwash; Drug: Xylitol; Drug: Probiotic

Interventions

Chlorhexidine mouthwash DRUG

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.

Also known as: Hexidine

Child Participants; Elderly Participants

Xylitol DRUG

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.

Also known as: Xylitol powder (Loba Chemie, code 06512)

Child Participants; Elderly Participants

Probiotic DRUG

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.

Also known as: Sporolac Plus powder- 1gm sachet

Child Participants; Elderly Participants

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Using mouth rinse routinely.
• Undergoing any dental treatment during the study period.
• Not able to brush their teeth and rinse on their own.

Sponsors & Collaborators

• Dr. Krupa NC: lead

Study Sites (1)

JSS Dental College & Hospital

Mysore, Karnataka, 570015, India

Location

Related Publications (1)

• Krupa NC, Thippeswamy HM, Chandrashekar BR. Antimicrobial efficacy of Xylitol, Probiotic and Chlorhexidine mouth rinses among children and elderly population at high risk for dental caries - A Randomized Controlled Trial. J Prev Med Hyg. 2022 Jul 31;63(2):E282-E287. doi: 10.15167/2421-4248/jpmh2022.63.2.1772. eCollection 2022 Jun.

  PMID: 35968060 DERIVED

MeSH Terms

Interventions

chlorhexidine gluconate; Xylitol; Probiotics

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Small number of subjects analyzed.

Results Point of Contact

• Title: Dr. Krupa NC
• Organization: JSS Dental College & Hospital, JSS Academy of Higher Education & Research

kripa_555@yahoo.com

8105064056

Study Officials

• Krupa NC

  JSS Academy of Higher Education & Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 22, 2020
• Study Start: February 15, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: July 22, 2020
• Results First Posted: July 22, 2020

Record last verified: 2020-07

Locations

IN (1)