Duangthip Duangporn, He Shuyang, Gao Sherry Shiqian, Chu Chun Hung, Lo Edward Chin Man
Restorative Dental Sciences, Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.
Applied Oral Sciences & Community Dental Care, Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.
JMIR Res Protoc. 2022 May 23;11(5):e35145. doi: 10.2196/35145.
Tooth decay is a significant public health problem globally. The caries-arrest effectiveness of 38% silver diamine fluoride (SDF) has been well documented. However, information on the caries-preventive effect of SDF on primary teeth is insufficient.
The aim of this trial is to investigate the effectiveness of semiannual application of 38% SDF and that of 5% sodium fluoride (NaF) varnish when compared with placebo control for preventing occlusal caries in the primary molars of preschool children over 30 months.
This 3-arm, parallel design, double-blind, randomized controlled trial involves 791 preschool children. Children are randomly allocated to receive 1 of 3 interventions as follows: Group 1, 38% SDF; Group 2, 5% NaF varnish; and Group 3, placebo control (tonic water). The intervention and dental examination will be carried out every 6 months. A parent-administered questionnaire, including the children's demographic background and oral health-related behaviors, has been collected at baseline. Follow-up examinations to detect new caries development will be conducted every 6 months by a masked examiner. Caries development will be diagnosed at the cavitation level. Chi-square tests and logistic regression analyses will be adopted. A 2-level logistic regression analysis will be performed to investigate the effects of the study interventions and other potential confounding factors on the development of occlusal caries.
This study was started on September 1, 2020, and the recruitment process ended on September 30, 2021. At present, a total of 791 children are participating in the study. This 30-month clinical trial is expected to be completed in March 2024.
If SDF application is more effective than NaF varnish for preventing caries on occlusal surfaces of primary teeth, it can be a preferred choice for caries prevention in a kindergarten-based program. Results of this trial will provide valuable clinical evidence for the development of oral health strategies and policies on the promotion of child oral health.
HKU Clinical Registry HKUCTR-2844, https://tinyurl.com/bdhz9yuk; ClinicalTrials.gov NCT05084001, https://clinicaltrials.gov/ct2/show/NCT05084001.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35145.
龋齿是全球一个重大的公共卫生问题。38%氟化亚锡（SDF）的防龋效果已有充分记录。然而，关于SDF对乳牙防龋作用的信息不足。
本试验旨在研究每半年应用一次38% SDF和5%氟化钠（NaF） varnish与安慰剂对照相比，对30个月以上学龄前儿童乳牙预防咬合面龋齿的有效性。
这项三臂、平行设计、双盲、随机对照试验涉及791名学龄前儿童。儿童被随机分配接受以下三种干预措施之一：第1组，38% SDF；第2组，5% NaF varnish；第3组，安慰剂对照（奎宁水）。干预和牙科检查每6个月进行一次。在基线时收集了一份由家长填写的问卷，包括儿童的人口统计学背景和与口腔健康相关的行为。由一名蒙面检查人员每6个月进行一次随访检查，以检测新龋齿的发展情况。龋齿发展将在出现龋洞水平进行诊断。将采用卡方检验和逻辑回归分析。将进行二级逻辑回归分析，以研究研究干预措施和其他潜在混杂因素对咬合面龋齿发展的影响。
本研究于2020年9月1日开始，招募过程于2021年9月30日结束。目前，共有791名儿童参与该研究。这项为期30个月的临床试验预计于2024年3月完成。
如果应用SDF在预防乳牙咬合面龋齿方面比NaF varnish更有效，那么它可以成为幼儿园项目中预防龋齿的首选。本试验结果将为制定促进儿童口腔健康的口腔健康策略和政策提供有价值的临床证据。
香港大学临床注册中心HKUCTR - 2844，https://tinyurl.com/bdhz9yuk；ClinicalTrials.gov NCT05084001，https://clinicaltrials.gov/ct2/show/NCT05084001。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/35145。
