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Completed
NCT04096599
Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
Conditions: Dental Caries
Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 579
Sponsor: Dr. Gillian Lee
Location: Paediatric Dentistry Hong Kong
Summary
The study will identify children at high caries risk and provide their parents/caregivers with evidence-based, risk-based at-home preventive measures for their infants, including daily use of xylitol or fluoride toothpaste. Infants aged 12-16 months with high caries risk will be invited to participate in the clinical trial. Each infant will be randomly allocated to one of two groups. In the test group, parents will be asked to use xylitol (25%) toothpaste to brush their toddler's teeth twice daily. Parents in the control group will be asked to use fluoride (1000ppm) toothpaste to brush their toddler's teeth twice daily. Identical oral health instruction and children's diet instruction will be given to every participant's caregivers.
For each dental examination, an examiner will assess dental caries and oral hygiene status of infants using a standard charting form. Caregivers will complete a questionnaire. The infants' plaque and saliva will be collected to quantify Streptococcus mutans. Data will be collected at baseline, one-year and two-year follow-ups.
The establishment of good oral health-related habits will safeguard and provide sustained benefits for the children. This study aims to provide evidence on the effectiveness of xylitol toothpaste and the risk of high fluoride toothpaste among young children. In the long term, findings from this study could provide the foundation for an effective oral health care promotion programme throughout Hong Kong and beyond. If shown to be effective, the framework could inform the development of oral health policies and promotion programmes to improve the oral health of young children.
Eligibility Criteria
Inclusion Criteria:
* Aged 12-16 months old
* High caries risk
Exclusion Criteria:
* Having systemic disease
Source: ClinicalTrials.gov (NCT04096599). StuddyBuddy aggregates publicly available trial information.