NCT02562456.

Trial name or title	Cost‐efficacy between ART and composite resin restorations in primary molars
Methods	Design: parallel RCT, single‐blind Country: Brazil
Participants	Inclusion criteria Children aged 3‐6 years In good health Whose parents or legal guardians accept and sign the consent form With ≥ 1 occlusal or occlusal proximal caries lesion in primary molars Only occlusal and/or occlusal‐proximal surfaces with caries lesions with dentin involvement Exclusion criteria Severe behavioral issues Presence of fistula or abscess near the selected tooth Presence of pulp exposure in the selected tooth Presence of mobility in the selected tooth
Interventions	Two treatment arms: Group 1: ART using H‐GIC (Fuji IX). No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments. Group 2: CT using Filtek Z‐350 composite resin. Local anaesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Access to caries lesion will be done using a round bur. Infected carious tissue will be removed with hand instruments.
Outcomes	Primary outcome Restoration survival Secondary outcome Child self‐reported discomfort Cost‐efficacy assessment
Starting date	October 2015
Contact information	Daniela P Raggio, PhD danielar@usp.br
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