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

NCT07245433 | Completed

• 1 other identifier: Faculty of Dentistry
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

xylitol wipes; mutans streptococci; lactic acid; early childhood caries; clinical trial

Outcome Measures

Primary Outcomes (2)

• Change in salivary lactic acid level

  Description: Lactic acid level in saliva measured using the Clinpro Cario-L-Pop chairside kit. Unit of Measure: Lactic acid score (1-9 scale).

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

• Change in salivary mutans streptococci (MS) count

  Description: Mutans streptococci colony density assessed using the CRT bacteria caries risk test. Unit of Measure: MS score (0-3 scale).

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

Secondary Outcomes (1)

• Parental compliance and tolerance to xylitol wipes

  Weekly for 4 weeks.

Other Outcomes (1)

• Ease of xylitol wipe application

  Weekly for 4 weeks.

Study Arms (1)

Xylitol Wipe Intervention

EXPERIMENTAL

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.

Other: Xylitol Dental Wipes

Interventions

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.

Xylitol Wipe Intervention

Eligibility Criteria

• Age: 9 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt, 21521, Egypt

Location

Related Publications (6)

• Babu V, Hegde S, Bhat S, Sargod S. Evaluation of Efficacy of Three Different Commercially Available Kit for Chairside Cariogenic Bacteria Test - Caries Risk Test, Saliva-check Mutans and CariScreen. Cureus. 2019 Dec 29;11(12):e6504. doi: 10.7759/cureus.6504.

  PMID: 32025425 RESULT

• Galganny-Almeida A, Queiroz MC, Leite AJ. The effectiveness of a novel infant tooth wipe in high caries-risk babies 8 to15 months old. Pediatr Dent. 2007 Jul-Aug;29(4):337-42.

  PMID: 17867402 RESULT

• Soderling E, Pienihakkinen K. Specific effects of xylitol chewing gum on mutans streptococci levels, plaque accumulation and caries occurrence: a systematic review. BMC Oral Health. 2025 Jul 29;25(1):1275. doi: 10.1186/s12903-025-06602-1.

  PMID: 40731400 RESULT

• Soderling EM. Xylitol, mutans streptococci, and dental plaque. Adv Dent Res. 2009;21(1):74-8. doi: 10.1177/0895937409335642. No abstract available.

  PMID: 19717413 RESULT

• Miyasawa-Hori H, Aizawa S, Takahashi N. Difference in the xylitol sensitivity of acid production among Streptococcus mutans strains and the biochemical mechanism. Oral Microbiol Immunol. 2006 Aug;21(4):201-5. doi: 10.1111/j.1399-302X.2006.00273.x.

  PMID: 16842502 RESULT

• Kishi M, Abe A, Kishi K, Ohara-Nemoto Y, Kimura S, Yonemitsu M. Relationship of quantitative salivary levels of Streptococcus mutans and S. sobrinus in mothers to caries status and colonization of mutans streptococci in plaque in their 2.5-year-old children. Community Dent Oral Epidemiol. 2009 Jun;37(3):241-9. doi: 10.1111/j.1600-0528.2009.00472.x.

  PMID: 19508271 RESULT

Study Officials

• Omar A El Meligy, BDS,MSc,PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Laila M El-Habashy, BDS,MSc,PhD

  Alexandria University and Pharos University

  PRINCIPAL INVESTIGATOR

• Aliaa A Hamouda, BDS,MSc,PhD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

EG (1)