Dental Caries Prevention, Early Childhood Caries (ECC), Oral Bacterial Colonization, Pediatric Oral Health
Conditions
Keywords
xylitol wipes, mutans streptococci, lactic acid, early childhood caries, clinical trial
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.
Detailed description
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.
Interventions
OTHERXylitol 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
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
9 Months to 18 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary lactic acid level | 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). |
| Change in salivary mutans streptococci (MS) count | 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
| Measure | Time frame | Description |
|---|---|---|
| Parental compliance and tolerance to xylitol wipes | 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
| Measure | Time frame | Description |
|---|---|---|
| Ease of xylitol wipe application | 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). |
Countries
Egypt
Outcome results
None listed