Supplemental Material for: Does detection of active initial caries lesions in primary teeth improve clinical outcomes? CARDEC-02 randomized controlled trial of diagnostic-treatment strategies guided by different caries detection thresholds

However, because the progression rate is relatively low, detecting initial lesions in the caries diagnosis strategy may be considered overdiagnosis, since one can expend additional unnecessary treatment with no relevant benefits for children. Thus, this study aimed to assess the impact on children's clinical outcomes of guiding dental treatment based on detecting active initial caries lesions versus ignoring initial caries lesions when assessing dental surfaces in primary teeth. <b>Methods:</b> A randomized controlled diagnostic-treatment trial was designed with 3- to 6-year-old participants and a 2-year follow-up.

Caries management interventions were defined based on two different diagnostic thresholds (diagnostic-treatment strategies) considering all caries lesions (including active initial caries) (ALL) or only advanced lesions (ADV). The primary outcome was the number of surfaces needing new operative interventions after two years. Secondary outcomes comprised the type of treatment performed at baseline, the number of new caries lesions after follow-up, the need for restoration replacement, endodontic treatment, or tooth extraction, and oral-health-related quality of life and parental satisfaction with the treatment.