This research was approved by the Scientific Ethics Committee of the Aysén Health Service. A non-randomized community trial was carried out in 4 rural areas (in the commune of Coyhaique) of southern Chile. A total of 208 children aged 2, 4 and 6 years were divided into 2 groups, Group I: n=101 children; Control group and Group 2 Group II: n=107; Intervention group. The control population received community fluoride applications twice per year in kindergarten, following the protocol of the government programme and access to dental care [16]. Simultaneously, parents received traditional oral health education at the local dental service. Oral health of these children was examined during 2016 and their oral status was registered, serving as the comparison for the data obtained for Group II. There was not sample size calculation, as all the children born in the localities during the period were included.
Children participating in the Early Smiles program (Group II; Intervention Group), received a promotional, preventive, and family-based dental approach through the following strategies (Figure 1):
1. Home dental visits to children aged between 6 and 8 months. Counselling and an anticipatory guideline about oral health was delivered, including central aspects for caries prevention: healthy diet and avoidance of sugars consumption, promotion of breastfeeding, tooth brushing and fluoride usage.
2. Follow-up at 12 months of age in the local dental service, included an oral health examination and behavioural change interventions based on the principles of motivational interviewing (MI). In addition, toothbrushing technique was reinforced.
3. Follow-up at 18 months of age at the dental service, including oral health examination, monitoring of established goals (from the previous session) and reinforcement of behavioural change interventions (MI).
4. Follow-up at 2 years of age at the local dental service included oral health examination and cariogenic risk assessment. Caries lesion detection and severity was undertaken using the International Caries Detection and Assessment System (ICDAS) [17]. The frequency of the controls and the type of intervention were defined based on the cariogenic risk assessed (Figure 2).
5. Integration of the interdisciplinary health care team. Professionals of the primary health care team at rural areas (physicians, nurses, nutritionists, psychologists, kinesiologists, social workers, and health technicians) were trained in the dental topics that were delivered in every visit, MI, and topics of cariology related to the prevention of ECC and minimal intervention approaches.
The Early Smiles program was carried out between 2017 and 2018. Only one dentist per location carried out all the interventions and evaluated all the children in the primary health care centres. A convenience sample including all 2-, 4- and 6-year-old rural children under dental health control in the towns of Balmaceda, El Blanco, Valle Simpson and Villa Ortega was obtained. Before examination, informed consent from the parents/tutors of the participants was obtained. Dentists of the primary health care team in rural areas (n=14) were trained in ICDAS by a calibrated expert examiner (RAG). Only ICDAS codes 3 to 6 were recorded to avoid diagnostic subjectivity of codes 1 and 2. Visual caries assessment was carried out without radiographs due to the lack of available equipment in the participant rural localities. From the data obtained with ICDAS, dmft, the number of cavitated carious lesions, caries rates, caries significance index (SiC) [18], and caries prevalence were calculated. Clinical evaluations were carried out by a dentist other than the one who performed the intervention. Data were analysed in SPSS version 23, and the Mann-Whitney U test was used to assess the significance of the results (95% significance level).