Dental caries Oral Health Dental caries
Conditions
Interventions
This is a four-armed, parallel-design randomized controlled trial that will follow the recommendations for Interventional Trials (SPIRIT) 2013 Statement. The study will include those children from fou
Sponsors
SDI Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children with one or more active carious lesions in primary tooth not involving the pulp 2. Participants who will begin the Healthy Kids Cambodia project in Takeo and Kampot provinces during the 2018-2019 academic year 3. Children in Grade 5 or below (age range 6-to 11 years of age)
Exclusion criteria
Exclusion criteria: 1. Children who are unable to provide adequate contact details/alternative contacts for reliable follow-up 2. Grade 6 and above children 3. Children belonging to families who have a plan to shift out of the region in the 12 months following recruitment 4. Children for whom their parents refuse consent at any stage during the study 5. Children who refuse assent at any stage during the study 6. Children with no teeth that are eligible to be included in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stability of carious lesions defined based on (a) lesion progression (b) lesion colour and (c) lesion texture at 6 months and 12 months. Method for measurement of outcomes will be through clinical observation of the size of the carious lesion using the International Caries Detection and Assessment System version II (ICDAS-II) as well as observation of the color of the carious lesion and the hardness of the carious lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| The presence or absence of oral symptoms as defined by the presence or absence of an ‘impact’ on oral symptoms using the oral symptoms domain of the previously validated Child Perceptions Questionnaire at 6 months and 12 months | — |
Countries
Cambodia
Outcome results
None listed