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NCT Number: NCT07245433

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

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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Key information

Age range

9 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt, 21521

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylitol Dental Wipes

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.

Primary outcomes

  1. Change in salivary lactic acid level

    Time frame: Baseline; weeks 1, 2, 3, and 4.

    Description: Lactic acid level in saliva measured using the Clinpro Cario-L-Pop chairside kit.

    Unit of Measure: Lactic acid score (1-9 scale).

  2. Change in salivary mutans streptococci (MS) count

    Time frame: Baseline; weeks 1, 2, 3, and 4.

    Description: Mutans streptococci colony density assessed using the CRT bacteria caries risk test.

    Unit of Measure: MS score (0-3 scale).

Secondary outcomes

  1. Parental compliance and tolerance to xylitol wipes

    Time frame: Weekly for 4 weeks.

    Description: Compliance is assessed by the number of wipes used per day, as reported by mothers during weekly interviews. During the same visits, mothers are asked whether any minor side effects (such as gastrointestinal discomfort or irritation) occurred in the child; these observations are recorded for monitoring purposes but are not treated as separate outcome variables.

    Unit of Measure: Number of wipes used per day.

Other outcomes

  1. Ease of xylitol wipe application

    Time frame: Weekly for 4 weeks.

    Description: Ease of application is assessed weekly using a structured questionnaire in which mothers rate how easy or difficult it was to use the xylitol wipes. During these interviews, mothers also report the child's acceptance of the wipe application (e.g., acceptance or refusal) and provide general feedback on satisfaction and willingness to continue use. These observations are recorded for context but are not treated as separate outcome variables.

    Unit of Measure: Ease-of-use rating (easy / moderate / difficult).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluating the Effect of Xylitol Wipes on Cariogenic Bacteria in Infants and Toddlers: A Longitudinal Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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