Evaluating the Effect of Xylitol Wipes on Cariogenic Bacteria in Infants and Toddlers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-11-01

Brief Summary

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This clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral bacteria associated with early childhood caries. A total of 20 healthy children aged 9 to 18 months are enrolled. Mothers are instructed to clean their children's teeth and gums using xylitol dental wipes three times daily after meals for four weeks. Saliva samples are collected at baseline and during weekly follow-up visits to measure lactic acid levels and mutans streptococci counts. A pediatric dentist examines each child at every visit to monitor general oral health and to check for any potential side effects. The study aims to assess the feasibility, safety, and potential preventive value of parent-applied xylitol wipes during early childhood.

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Detailed Description

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This longitudinal interventional study is designed to assess the preventive effect of xylitol-containing dental wipes on oral bacteria linked to early childhood caries (ECC). The study enrolls 20 healthy, caries-free infants and toddlers aged 9 to 18 months attending the Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University. After obtaining informed consent, mothers are instructed to use commercially available xylitol dental wipes (Spiffies Baby Tooth Wipes™, Dr. Products Inc., USA) to clean their children's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contains a xylitol-based solution intended to provide mechanical cleaning and daily exposure to approximately 4.2 g of xylitol.

Saliva samples are collected at baseline and at four weekly follow-up visits. Two primary outcome measures are assessed:

Lactic acid levels, using the Clinpro Cario-L-Pop chairside kit (3M ESPE, Germany) Mutans streptococci counts, using the CRT Bacteria Caries Risk Test (Ivoclar Vivadent, Liechtenstein) Participants are monitored weekly to assess compliance, document any dietary changes, and report potential side effects, including mild gastrointestinal symptoms. Children undergo oral examinations by a pediatric dentist at each visit to evaluate oral tissues and overall tolerance of the intervention.

The study protocol focuses on determining whether the regular use of xylitol wipes is feasible, acceptable to parents and children, and potentially useful as a preventive measure against early childhood oral bacterial activity.

Conditions

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Early Childhood Caries (ECC) Dental Caries Prevention Oral Bacterial Colonization Pediatric Oral Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-group, before-after longitudinal design. All enrolled children (9 months to 1.5 years) received the same intervention: mothers used commercially available xylitol dental wipes for their child 3 times daily for 4 weeks (4.2g/day). Outcomes (salivary lactic acid via Clinpro Cario-L-Pop and mutans streptococci counts via CRT kit) were measured at baseline and weekly for 4 visits. Compliance and adverse events were checked at each visit. No randomization or masking.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Xylitol Wipe Intervention

All participants (children aged 9-18 months) in this single-arm study received the same intervention. Mothers were instructed to use commercially available xylitol dental wipes to clean their child's teeth and gums three times daily after meals for four weeks. Each wipe provided an estimated total daily xylitol exposure of about 4.2 g.

The purpose of the intervention was to evaluate its preventive effect on early childhood caries by reducing cariogenic bacterial activity. The primary outcomes measured were:

Salivary lactic acid levels using the Clinpro Cario-L-Pop chairside test kit. Mutans streptococci counts using the CRT bacteria caries risk test. All children were monitored weekly for compliance, oral health status, and any minor side effects. No comparator or placebo arm was included.

Group Type EXPERIMENTAL

Xylitol Dental Wipes

Intervention Type OTHER

Commercially available xylitol dental wipes were used for daily oral cleaning in infants and toddlers. Mothers were instructed to wipe their child's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contained a xylitol-based solution providing a total daily exposure of approximately 4.2 g of xylitol. The intervention aimed to reduce cariogenic bacterial activity and prevent early childhood caries. Compliance, tolerance, and any minor side effects were recorded weekly during follow-up visits.

Interventions

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Xylitol Dental Wipes

Commercially available xylitol dental wipes were used for daily oral cleaning in infants and toddlers. Mothers were instructed to wipe their child's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contained a xylitol-based solution providing a total daily exposure of approximately 4.2 g of xylitol. The intervention aimed to reduce cariogenic bacterial activity and prevent early childhood caries. Compliance, tolerance, and any minor side effects were recorded weekly during follow-up visits.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Healthy infants and toddlers aged 9 months to 18 months

Caries-free (no visible dental decay or white spot lesions)

Cooperative child and mother willing to participate for 4 weeks

Mother able to understand and follow instructions for xylitol wipe use

Written informed consent obtained from parent or legal guardian

Exclusion Criteria

Infants or toddlers with systemic diseases or medical conditions affecting saliva

Use of antibiotics or antimicrobial mouth products within the past 4 weeks

Known allergy or sensitivity to xylitol or product components

Existing oral lesions or ongoing dental treatment

Non-compliance with study protocol or loss to follow-up

Minimum Eligible Age

9 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes