Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.
Cruzeiro do Sul University, São Paulo, Brazil.
Community Dent Oral Epidemiol. 2023 Oct;51(5):804-812. doi: 10.1111/cdoe.12765. Epub 2022 Jun 7.
This randomized clinical trial aimed to evaluate the influence of two caries diagnosis strategies, and subsequent management, on oral health-related quality of life (OHRQoL) of preschoolers. Additionally, the association of the OHRQoL outcomes with the clinician-centred primary outcome used in the main study was also explored.
This study refers to the OHRQoL secondary outcomes analyses of the so-called RCT 'CARDEC-1'. Three- to 6-year-old children were randomly allocated in two caries detection strategies in primary molars: visual inspection (VIS) or visual + radiographic (RAD) assessment. Participants were diagnosed and treated according to the allocated group and followed up for 2 years. Caregivers answered the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and after 2 years. Intention-to-treat analysis was performed. ECOHIS scores at baseline and 2 years later were compared using the Mann-Whitney test. Effect sizes, change scores and the minimally important difference (MID) were also compared between groups. Additional analysis was performed to assess if OHRQoL variables could reflect the primary clinical outcome (number of new operative interventions during the follow-up), observing if these met the Prentice criteria.
Two hundred and five children had the ECOHIS answered in both period times (18.7% attrition rate). There was a decrease in total ECOHIS scores, as well as for different domains for both trial groups, with effect sizes varying from 0.43 to 0.77. Comparisons between groups, however, did not show significant differences. In the additional analysis, the OHRQoL variables met the Prentice criteria and presented the same trends observed with the clinician-centred primary endpoint.
Caries detection performed by visual inspection alone or associated with radiographic method does not influence the long-term impact on OHRQoL. Furthermore, OHRQoL variables reflect clinical outcomes in this type of clinical trial.
gov NCT02078453.
本随机临床试验旨在评估两种龋病诊断策略及其后续管理对学龄前儿童口腔健康相关生活质量（OHRQoL）的影响。此外，还探讨了 OHRQoL 结果与主要研究中使用的以临床医生为中心的主要结局之间的关系。
本研究是所谓 RCT“CARDEC-1”的 OHRQoL 次要结局分析。将 3 至 6 岁的儿童随机分配到两种乳磨牙龋病检测策略中：目视检查（VIS）或目视+放射照相（RAD）评估。参与者根据分配的组别进行诊断和治疗，并随访 2 年。监护人在基线和 2 年后回答幼儿口腔健康影响量表（ECOHIS）。采用意向治疗分析。使用 Mann-Whitney 检验比较基线和 2 年后的 ECOHIS 评分。还比较了组间的效应大小、变化分数和最小重要差异（MID）。进行了额外的分析，以评估 OHRQoL 变量是否可以反映主要临床结局（随访期间新手术干预的数量），观察这些变量是否符合 Prentice 标准。
205 名儿童在两个时间段均回答了 ECOHIS（18.7%的失访率）。两个试验组的 ECOHIS 总分以及不同领域的分数均有所下降，效应大小从 0.43 到 0.77 不等。然而，组间比较并未显示出显著差异。在额外的分析中，OHRQoL 变量符合 Prentice 标准，并呈现出与以临床医生为中心的主要终点相同的趋势。
单独进行目视检查或与放射照相方法联合进行的龋病检测不会对 OHRQoL 的长期影响产生影响。此外，OHRQoL 变量反映了此类临床试验中的临床结局。
gov NCT02078453。
