Dental Caries
Conditions
Keywords
Oral health, Early childhood caries, Toothbrushing, Dentifrices, Randomised clinical trial, Xylitol
Brief 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.
Interventions
OTHERXylitol toothpaste
At-home preventive measures + xylitol-containing (25%) toothpaste
OTHERFluoride toothpaste
At-home preventive measures + fluoride (1000 ppm F) toothpaste
Sponsors
Dr. Gillian Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Aged 12-16 months old * High caries risk
Exclusion criteria
* Having systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental caries (cavitated lesion) | Baseline, 1-year and 2-year follow-up | Active caries into dentine will be diagnosed at the cavitation level through careful visual inspection. A ball-ended CPI probe will be used to remove food debris or plaque that may obscure visual inspection whenever it is necessary. The degree and severity of the carious lesions will be recorded using Modified International Caries Detection and Assessment System (ICDAS II) caries severity codes (0 to 6). The proportion of toddlers with a cavitated lesion (CL, ICDAS II codes 3-6) will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental caries (white spot lesion) | Baseline, 1-year and 2-year follow-up | Active caries into dentine will be diagnosed at the cavitation level through careful visual inspection. A ball-ended CPI probe will be used to remove food debris or plaque that may obscure visual inspection whenever it is necessary. The degree and severity of the carious lesions will be recorded using Modified International Caries Detection and Assessment System (ICDAS II) caries severity codes (0 to 6). The proportion of toddlers with a white spot lesion (WSL, ICDAS II codes 1 and 2) will be calculated. |
| Dental caries experience (dmft) | Baseline, 1-year and 2-year follow-up | Active caries into dentine will be diagnosed at the cavitation level through careful visual inspection. A ball-ended CPI probe will be used to remove food debris or plaque that may obscure visual inspection whenever it is necessary. The dental caries experience of the toddlers will be recorded as the number of decayed, missing, and filled primary teeth (dmft index). |
| Oral hygiene status (VPI) | Baseline, 1-year and 2-year follow-up | Dental plaque deposits on the buccal, palatal/lingual, mesial and distal surfaces of all erupted primary teeth were examined. Plaque index (PI) (score 0, 1, 2, 3) will be used to record the amount of dental plaque accumulation (Silness \& Löe, 1964). The proportion of toddlers with visible plaque (VP) will be calculated based on codes 2 and 3. |
| Streptococcus mutans (MS) | Baseline, 1-year and 2-year follow-up | Plaque and saliva samples will be collected from the surfaces of the primary teeth and then processed following the protocol by Paster et al. (2001). 'Species-specific' Taqman (real-time) quantitative polymerase chain reaction (Q-RT-PCR) will be used to provide DNA template for quantitative analysis of S. mutans levels. |
Countries
China
Contacts
STUDY_CHAIRGillian Lee, Doctor
The University of Hong Kong
Outcome results
None listed