Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.
Trials. 2021 Aug 4;22(1):519. doi: 10.1186/s13063-021-05496-y.
Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF in young children, (ii) to determine children's and parents' acceptance of these fluoride therapies and (iii) to investigate the short-term (1 day) and long-term (1 year) adverse effects of these fluoride therapies.
METHODS/DESIGN: This is a randomised, double-blind, active-controlled clinical trial to be conducted in Hong Kong kindergartens. The study has received approval from the local institutional review board. Written consent will be obtained from the parents/guardians before the study. The study will recruit at least 688 healthy 3-year-old children. This sample size is sufficient for an appropriate statistical analysis. Stratified randomisation will be performed for intervention allocation. The two intervention groups are 38% SDF and 5% NaF varnish applied on six primary upper anterior teeth. At baseline, one trained examiner will perform clinical examinations of the children in the kindergartens. The caries experience and oral hygiene status of each child will be recorded using the decayed, missing (due to caries) and filled primary tooth index and visual plaque index, respectively. Then, an independent operator will apply the assigned fluoride after the dental examinations. The examiner, the children and their parents will be blinded to the intervention allocation. In addition, a research assistant will evaluate the child's acceptance using interval rating scales for children's uncooperative behaviour. The examiner will then visit the children the next day to study the short-term potential adverse effects of the fluoride therapies. The same examiner will perform a follow-up examination after 1 year to evaluate the children's caries experiences, their oral hygiene statuses and the adverse effects of the fluoride. Parental questionnaires will be used to assess parental satisfaction and concerns about the fluoride therapies.
This study provides essential information about using SDF in an outreach kindergarten service for caries management from different aspects, which include the caries-arresting and caries-preventive effects, the adverse effects and children's and parents' acceptance. The success of the service can help to increase the adoption of SDF to reduce the global burden of early childhood caries.
ClinicalTrials.gov NCT04399369 . Registered on May 2020.
银胺氟化（SDF）和氟化钠（NaF）被广泛用于龋齿管理。本研究的目的是：（i）比较 SDF 和 NaF 在幼儿中的龋齿抑制和预防效果；（ii）确定儿童和家长对这些氟化物治疗的接受程度；（iii）调查这些氟化物治疗的短期（1 天）和长期（1 年）不良影响。
方法/设计：这是一项在香港幼儿园进行的随机、双盲、活性对照临床试验。该研究已获得当地机构审查委员会的批准。在研究开始前，将获得家长/监护人的书面同意。该研究将招募至少 688 名健康的 3 岁儿童。这个样本量足以进行适当的统计分析。将对干预分配进行分层随机化。两组干预措施分别为：38%的 SDF 和 5%的 NaF 涂料涂于六颗上前牙。在基线时，一名经过培训的检查者将在幼儿园对儿童进行临床检查。每一名儿童的龋齿情况和口腔卫生状况将分别使用龋失补牙指数和视诊菌斑指数进行记录。然后，一名独立的操作者将在牙科检查后应用指定的氟化物。检查者、儿童及其家长将对干预分配保持盲态。此外，研究助理将使用儿童不合作行为的间隔评分量表评估儿童的接受程度。然后，检查者将在第二天访问儿童，以研究氟化物治疗的短期潜在不良影响。同一名检查者将在 1 年后进行随访检查，以评估儿童的龋齿情况、口腔卫生状况以及氟化物的不良反应。家长问卷将用于评估家长对氟化物治疗的满意度和关注。
本研究从不同方面提供了有关在社区幼儿园服务中使用 SDF 进行龋齿管理的重要信息，包括龋齿抑制和预防效果、不良反应以及儿童和家长的接受程度。该服务的成功将有助于增加 SDF 的应用，以减轻全球儿童早期龋齿的负担。
ClinicalTrials.gov NCT04399369。于 2020 年 5 月注册。
