背景:二氟化银(SDF)作为一种简单的,具有成本效益的方法,以尽量减少敏感性和阻止龋齿。然而,SDF导致龋齿被染成黑色。用SDF的碘化钾(KI)处理可以最小化或减轻染色。然而,尚未研究KI对染色的有效性。证明碘化钾减少黑色染色的研究仍然不足。本文介绍了健康微笑的研究协议,一项随机对照试验,旨在比较SDF和SDF+KI的染色倾向。
目的:本研究,健康的微笑,旨在使用NixMini颜色传感器评估4至6岁儿童中SDF和SDFKI的染色倾向。该研究的另一个目的是评估SDF和SDFKI在龋齿基牙治疗中的防龋效果。
方法:本研究为随机对照试验。共60名符合国际龋齿检测和评估系统(代码1或以上)标准的龋齿儿童将被随机分配到治疗组,其中第1组将用SDF治疗,第2组将用SDF+KI治疗。将使用NixMini颜色传感器以数字方式评估治疗的病变的变色。参与者将在治疗后1、3和6个月进行随访,以使用NixMini颜色传感器以数字方式记录ΔL和ΔE值。将使用SPSS(28版;IBMCorp)分析数据。将使用独立样本t检验和Mann-WhitneyU检验来比较2组。
结果:注册于2023年10月开始。预计注册期为12个月。数据收集计划于2024年完成。
结论:论文描述了快乐的微笑,该项目提供了一个机会来解决患者的美学不便,而又不影响SDF治疗的有效性。试验结果将有助于SDF干预后与变色相关的有限证据基础,以改善儿童口腔健康的美学外观。如果试验结果有希望,这将导致儿童口腔健康模型的发展,并为儿童口腔健康的进一步研究铺平道路。
■PRR1-10.2196/51087。
BACKGROUND: Silver diamine fluoride (SDF) is becoming more widely recognized as a simple, cost-effective approach to minimize sensitivity and arrest caries. However, SDF results in caries that are stained black. Potassium iodide (KI) treatment with SDF may minimize or lessen the staining. However, the effectiveness of KI on staining has not been investigated. Studies demonstrating that potassium iodide reduces the black staining are still insufficient. This paper presents the study protocol for Healthy Smiles, a randomized controlled trial implemented to compare the staining propensity of SDF and SDF+KI.
OBJECTIVE: This study, Healthy Smiles, aims to evaluate the staining propensity of SDF and SDF+KI using a Nix Mini color sensor among children aged 4 to 6 years. Another objective of the study is to evaluate the caries-arresting effect of SDF and SDF+KI in the treatment of carious primary teeth.
METHODS: This study is a randomized controlled trial. A total of 60 children with caries that meet the criteria of the International Caries Detection and Assessment System (code 1 or above) will be randomly assigned to treatment groups, where group 1 will be treated with SDF and group 2 will be treated with SDF+KI. Discoloration of treated lesions will be assessed digitally using a Nix Mini color sensor. Participants will be followed up at 1, 3, and 6 months after treatment to digitally record the ∆L and ∆E values using the Nix Mini color sensor. Data will be analyzed using SPSS (version 28; IBM Corp). Independent sample t tests and the Mann-Whitney U test will be used to compare the 2 groups.
RESULTS: Enrollment started in October 2023. It is estimated that the enrollment period will be 12 months. Data collection is planned to be completed in 2024.
CONCLUSIONS: The presented paper describes Happy Smiles, a project that provides an opportunity to address the aesthetic inconvenience of patients without compromising the effectiveness of the SDF treatment. The trial findings will contribute to the limited evidence base related to discoloration after SDF intervention to improve aesthetic appearances in child oral health. If the results from the trial are promising, it will lead to the development of a model for child oral health and pave the way for further research in child oral health.
UNASSIGNED: PRR1-10.2196/51087.