CompletedNot Applicable

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

Egypt20 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range

9 Months – 18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in salivary lactic acid level

Timeframe: Baseline; weeks 1, 2, 3, and 4.

Change in salivary mutans streptococci (MS) count

Timeframe: Baseline; weeks 1, 2, 3, and 4.

Trial details

NCT IDNCT07245433

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Early Childhood Caries (ECC) trials