Cavity Management Effectiveness and Feasibility of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish in Children: One-Year Follow-Up Non-Inferiority Randomised Controlled Trial.

IF 2.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE
Caries Research Pub Date : 2025-04-23 DOI:10.1159/000544953
Stefania Martignon, Margarita Usuga-Vacca, Andrea Cortes, Sofía Jácome-Liévano, Natalia Fortich-Mesa, Emilia María Ochoa, Roquelina Pianeta, Vivi Hoyos-Hoyos, Edgar O Beltrán
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引用次数: 0

Abstract

Introduction: The prevalence of caries experience among 5-year-old children in Colombia remains high (62%). The National Health System supports the use of NaF varnish (FV) from age one. Considering the inclusion of SDF solution (SDF) by the WHO and the FDI to control caries burden by 2030, the aim of this non-inferiority randomised controlled trial (RCT) was to compare after 1 year the effectiveness and feasibility of biannual applications of SDF or FV for the control of cavities in young children from Bogotá and Cartagena, Colombia.

Methods: This non-inferiority RCT included seven hundred fifty-two 3- to 4-year-old medically healthy children from Bogotá and Cartagena. Participants in each city were randomised to receive either SDF (38%) or FV (5%) biannually.

Primary outcome: cavity (d) prevention effect.

Secondary outcomes: active cavity (active d) arresting effect, feasibility (study adherence, received treatment fidelity), dental care parental satisfaction/acceptance, child procedure behaviour and pain, and adverse effects. Data were analysed using t tests, χ2 tests, and generalised estimating equation (0.05 statistical significance).

Results: A total of 611 children (75.1%) completed the 1-year follow-up. At baseline, overall prevalence of caries experience (dmf) was of 32% (prevalence of d: 27%), increasing to over 75% when including initial and moderate caries lesions (assessed without air-drying, Epi) (ICDAS-merged Epi dmf). Corresponding mean number of tooth surfaces with ICDAS-merged Epi dmf was >5.9, of which cavities/d >1.1. Most reported a high daily intake of free sugars (FV: 82.8%; SDF: 79.9%), and use of fluoridated toothpaste was not generalised (FV: 60.3%; SDF: 57.8%). After 1 year, mean number of new cavity tooth surfaces showed no inferiority for SDF versus FV (FV: 0.61 ± 1.86; SDF: 0.40 ± 1.13, p = 0.22). Arresting active cavities was achieved in 49.4% (FV) and 72.2% (SDF) of children (p > 0.05). Feasibility was high: study adherence (FV: 76.1%; SDF: 74.0%); received treatment fidelity (FV: 92.9%; SDF: 91.4%) (p > 0.05). Most parents were satisfied-very satisfied (FV: 93.2%; SDF: 96.0%) (p > 0.05). Only one case of adverse effects appeared after the first fluoride application (SDF) and resolved uneventfully.

Conclusion: After 1 year, a biannual application of SDF versus FV was not inferior in preventing new cavities, with high feasibility in community settings. This study supports the use of these fluoride therapies for young children in similar socio-economic contexts, recommending increasing fluoridated toothpaste affordability and including behaviour change strategies to improve oral health practices.

SDF溶液和NaF清漆治疗儿童龋齿的有效性和可行性:1年随访非劣效性随机对照试验。
哥伦比亚5岁儿童的龋病患病率仍然很高(62%)。国家卫生系统支持从一岁开始使用NaF清漆(FV)。考虑到世界卫生组织和FDI将SDF溶液(SDF)纳入到2030年控制龋齿负担,本非劣效性随机对照试验(RCT)的目的是在一年后比较每两年应用SDF或FV控制波哥大和卡塔赫纳幼儿龋齿的有效性和可行性。方法:该非劣效性随机对照试验纳入752名来自波哥大和卡塔赫纳的3-4岁医学健康儿童。每个城市的参与者每半年随机接受SDF(38%)或FV(5%)。主要观察结果:预防蛀牙效果。次要结局:主动牙洞(active-d)阻滞效果、可行性(研究依从性、接受治疗的忠实度)、牙科护理父母满意度/接受度、儿童手术行为和疼痛,以及不良反应。数据分析采用t检验、卡方检验和广义估计方程(GEE),差异有统计学意义(0.05)。结果:611例患儿(75.1%)完成1年随访。基线时,龋齿经历(dmf)的总体患病率为32% (d患病率为27%),当包括初始和中度龋齿病变(在没有风干的情况下评估,Epi) (icdas合并Epi dmf)时增加到75%以上。与icdas合并的Epi dmf对应的平均牙面数为>5.9,其中牙槽数/d为>1.1。大多数报告每日游离糖摄入量高(FV: 82.8%;SDF: 79.9%),含氟牙膏的使用没有推广(FV: 60.3%;自卫队:57.8%)。一年后,SDF与FV的平均新牙面数无明显差异(FV: 0.61±1.86;SDF: 0.40±1.13,p=0.22)。49.4%的儿童(FV)和72.2%的儿童(SDF)达到抑制活动腔(p < 0.05)。可行性高:研究依从性(FV: 76.1%;自卫队:74.0%);治疗保真度(FV: 92.9%;SDF: 91.4%) (p < 0.05)。大多数家长满意-非常满意(FV: 93.2%;SDF: 96.0%) (p < 0.05)。只有一例不良反应出现在第一次氟化物应用(SDF)后,并顺利解决。结论:1年后,每两年应用一次的SDF与FV在预防新牙洞方面并不逊色,在社区环境中具有很高的可行性。这项研究支持对处于类似社会经济背景下的幼儿使用这些氟化物疗法,建议提高含氟牙膏的可负担性,并包括行为改变策略以改善口腔健康习惯。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Caries Research
Caries Research 医学-牙科与口腔外科
CiteScore
6.30
自引率
7.10%
发文量
34
审稿时长
6-12 weeks
期刊介绍: ''Caries Research'' publishes epidemiological, clinical and laboratory studies in dental caries, erosion and related dental diseases. Some studies build on the considerable advances already made in caries prevention, e.g. through fluoride application. Some aim to improve understanding of the increasingly important problem of dental erosion and the associated tooth wear process. Others monitor the changing pattern of caries in different populations, explore improved methods of diagnosis or evaluate methods of prevention or treatment. The broad coverage of current research has given the journal an international reputation as an indispensable source for both basic scientists and clinicians engaged in understanding, investigating and preventing dental disease.
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