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

NCT07245433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-24

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Omar A El Meligy, BDS,MSc,PhD · Alexandria University

  • Laila M El-Habashy, BDS,MSc,PhD · Alexandria University and Pharos University

  • Aliaa A Hamouda, BDS,MSc,PhD · Alexandria University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-06-01
Completion
2025-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245433 on ClinicalTrials.gov