| Summary: | <p>Abstract</p> <p>Background</p> <p>Occlusal surfaces of erupting and newly erupted permanent molars are particularly susceptible to caries.</p> <p>The objective of the study was to assess and compare the effect of a single application of 38% SDF with ART sealants and no treatment in preventing dentinal (D3) caries lesions on occlusal surfaces of permanent first molars of school children who participated in a daily school-based toothbrushing program with fluoride toothpaste.</p> <p>Methods</p> <p>The prospective community clinical trial in the Philippines was conducted over a period of 18 months and included 704 six- to eight-year-old school children in eight public elementary schools with a daily school-based fluoride toothpaste brushing program. Children were randomly assigned for SDF application or ART sealant treatment. Children from two of the eight schools did not receive SDF or ART sealant treatment and served as controls. SDF or ART sealant treatment was applied on sound occlusal surfaces of permanent first molars. Surfaces that were originally defined as sound at baseline but which changed to dentinal (D3) caries lesions were defined as surfaces with new caries (caries increment). Non-compliance to the daily toothbrushing program in three schools offered the opportunity to analyze the caries preventive effect of SDF and sealants separately in fluoride toothpaste brushing and in non-toothbrushing children.</p> <p>Results</p> <p>In the brushing group, caries increment in the SDF treatment group was comparable with the non-treatment group but caries increment in the sealant group was lower than in the non-treatment group with a statistically significant lower hazard ratio of 0.12 (0.02-0.61). In the non-brushing group, caries increment in the SDF treatment group and the sealant group was lower than the non-treatment group but the hazard ratio was only statistically significant for the sealant group (HR 0.33; 0.20-0.54). Caries increment was lower in toothbrushing children than in non-toothbrushing children. Hazard ratios reached statistical significance for the non-treated children (HR 0.43; 0.21-0.87) and the sealant-treated children (HR 0.15; 0.03-0.072).</p> <p>Conclusions</p> <p>A one-time application of 38% SDF on the occlusal surfaces of permanent first molars of six- to eight-year-old children is not an effective method to prevent dentinal (D3) caries lesions. ART sealants significantly reduced the onset of caries over a period of 18 months.</p> <p>Trial registration number</p> <p>German Clinical Trial Register DRKS00003427</p>
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