Muller-Bolla Michèle, Pierre Audrey, Lupi-Pégurier Laurence, Velly Ana M
Department of Paediatric Dentistry, Faculty of Dentistry, UNS-UCA (Nice Sophia Antipolis University), CHUN, Nice, France.
Laboratory URB2i - EA 4462, Paris Descartes, Paris, France.
Community Dent Oral Epidemiol. 2016 Oct;44(5):504-11. doi: 10.1111/cdoe.12241. Epub 2016 Jun 28.
A split-mouth randomized clinical trial was carried out to assess the effectiveness of a school-based dental sealant (SBDS) program for French children from low-income backgrounds within 3 years of follow-up. The secondary objectives were to determine the risk factors for the occurrence of new carious lesions (ICDAS 3-6) on first permanent molars, to evaluate the effectiveness of the program according to risk factors and to assess sealant retention.
The study included 276 6- to 7-year old pupils (457 pairs of first permanent molars) from Nice. The sealing was performed in first- or second-grade children. The first permanent molars were randomized into two groups: One received resin-based sealant and the other formed a nontreatment group. Carious lesions ICDAS 3-6 on permanent and primary teeth, visible plaque, streptococcus mutans and/or lactobacillus counts were recorded at baseline to assess individual caries risk (ICR). The putative confounders recorded at baseline were sex, grade level, and characteristics of first permanent molars. An intent-to-treat analysis was performed, where the study outcome was the occurrence of new carious lesions within 3 years of follow-up. Univariate and multivariate Cox proportional hazards models (hazard risk, HR) using the procedure PHREG with the option of Covsandwich were performed in SAS to assess the effectiveness of the SBDS program.
At 3 years of follow-up, 228 children (378 tooth pairs) remained in the analysis. The survival analysis showed that first permanent molars that received sealants had 67% (adjusted HR: 0.33; 95% CI: 0.24-0.46) less risk of developing new carious lesions during all the follow-up than molars without sealant. In addition, children with carious lesions ICDAS 3-6 on permanent and primary teeth, that is, high ICR, had three times the risk of having a new carious lesion than others without, independently of the sealant treatment (adjusted HR: 3.00; 95% CI: 1.55-5.75). Effectiveness of the SBDS program at 3 years of follow-up depended on the presence of carious lesions ICDAS 3-6 (HR in 173 children with carious lesions: 0.32; 95% CI: 0.23-0.46) at baseline (HR in 103 children without carious lesions: 0.42; 95% CI: 0.16-1.12). Finally, the overall retention rate was 32.3%.
The effectiveness of the SBDS program was demonstrated in low socioeconomic areas. Selection of schoolchildren according to the presence of carious lesions ICDAS 3-6 should be considered in a SBDS program.
开展一项半口随机临床试验，以评估一项针对来自低收入家庭背景的法国儿童的校内窝沟封闭剂（SBDS）项目在3年随访期内的有效性。次要目标是确定第一恒磨牙上新发龋损（国际龋病检测与评估系统[ICDAS] 3 - 6级）发生的风险因素，根据风险因素评估该项目的有效性，并评估窝沟封闭剂的保留率。
该研究纳入了来自尼斯的276名6至7岁小学生（457对第一恒磨牙）。窝沟封闭在一、二年级儿童中进行。第一恒磨牙被随机分为两组：一组接受树脂基窝沟封闭剂，另一组为未治疗组。在基线时记录恒牙和乳牙上的ICDAS 3 - 6级龋损、可见菌斑、变形链球菌和/或乳酸杆菌计数，以评估个体龋病风险（ICR）。在基线时记录的可能混杂因素为性别、年级以及第一恒磨牙的特征。进行意向性分析，研究结局为随访3年内新发龋损的发生情况。在SAS中使用带有Covsandwich选项的PHREG过程进行单变量和多变量Cox比例风险模型（风险比，HR）分析，以评估SBDS项目的有效性。
在3年随访时，228名儿童（378对牙齿）仍纳入分析。生存分析表明，接受窝沟封闭剂的第一恒磨牙在整个随访期间发生新发龋损的风险比未接受窝沟封闭剂的磨牙低67%（校正HR：0.33；95%置信区间：0.24 - 0.46）。此外，恒牙和乳牙有ICDAS 3 - 6级龋损（即高ICR）的儿童发生新发龋损的风险是其他无龋损儿童的三倍，与窝沟封闭剂治疗无关（校正HR：3.00；95%置信区间：1.55 - 5.75）。SBDS项目在3年随访时的有效性取决于基线时是否存在ICDAS 3 - 6级龋损（173名有龋损儿童的HR：0.32；95%置信区间：0.23 - 0.46）（103名无龋损儿童的HR：0.42；95%置信区间：0.16 - 1.12）。最后，总体保留率为32.3%。
SBDS项目在社会经济地位较低地区的有效性得到了证实。在SBDS项目中应考虑根据是否存在ICDAS 3 - 6级龋损来选择在校儿童。
