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 thresholds.

INTRODUCTION: Early detection of caries lesions has been encouraged to prevent their progression. 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. METHODS: 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. An intention-to-treat analysis was conducted, and negative binomial regression was used for comparisons. RESULTS: Of the 260 participants included, 222 were followed up (14.6% attrition rate). No difference was observed between groups for the primary outcome (p=0.827). For the secondary outcomes, children allocated to the ALL group had more non-operative procedures and a higher number of sessions with professional fluoride application. For other secondary outcomes, the groups did not differ. CONCLUSION: Detecting active initial caries lesions and guiding dental treatment focused on these lesions does not decrease the new operative interventions in primary teeth compared to when these initial lesions are ignored. TRIAL REGISTRATION: NCT02473107. Registered June 16, 2015.