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
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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