Department of Preventive Dental Science, Dr. Gerald Niznick College of Dentistry, Rady Faculty of Health Sciences, University of Manitoba, 507-715 McDermot Avenue, Winnipeg, MB, R3E 3P4, Canada.
Department of Pediatrics and Child Health, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
BMC Oral Health. 2024 Sep 4;24(1):1036. doi: 10.1186/s12903-024-04791-9.
Silver diamine fluoride (SDF) is an antimicrobial agent and alternative treatment option that can be used to arrest dental decay. While there is optimism with SDF with regard to caries management, there is no true consensus on the number and frequency of applications for children. The purpose of this study was to examine the effectiveness of 38% SDF to arrest early childhood caries (ECC) at three different application regimen intervals.
Children with teeth that met International Caries Detection and Assessment System codes 5 or 6 criteria were recruited from community dental clinics into an open-label, parallel-group, randomized clinical trial from October 2019 to June 2021. Participants were randomized to one of three groups using sealed envelopes that were prepared with one of three regimens inside: visits one month, four months, or six months apart. Participants received applications of 38% SDF, along with 5% sodium fluoride varnish (NaFV), at the first two visits to treat cavitated carious lesions. Lesions were followed and arrest rates were calculated. Lesions were considered arrested if they were hard on probing and black in colour. Statistics included descriptive and bivariate analyses (Kruskal one-way analysis of variance and Pearson's Chi-squared test). A p-value of ≤ 0.05 was considered significant.
Eighty-four children participated in the study (49 males and 35 females, mean age: 44.4 ± 14.2 months). Treatment groups were well matched with 28 participants per group. A total of 374 teeth and 505 lesions were followed. Posterior lesions represented only 40.6% of affected surfaces. Almost all SDF treated lesions were arrested for the one-month (192/196, 98%) and four-month (159/166, 95.8%) interval groups at the final visit. The six-month group experienced the lowest arrest rates; only 72% (103/143) of lesions were arrested (p < 0.001). The duration of application intervals was inversely associated with improvements in arrest rates for all lesions.
Two applications of 38% SDF and 5% NaFV in one-month and four-month intervals were comparable and very effective in arresting ECC. Applications six months apart were less effective and could be considered inferior treatment.
ClinicalTrials.gov NCT04054635 (first registered 13/08/2019).
银胺氟（SDF）是一种具有抗菌作用的药物，也是一种可供选择的治疗方法，可用于阻止龋齿的发展。尽管 SDF 在龋齿管理方面被寄予厚望，但对于儿童来说，应用的次数和频率尚无真正的共识。本研究的目的是检验 38% SDF 在三种不同应用方案间隔时间下对早期儿童龋（ECC）的疗效。
2019 年 10 月至 2021 年 6 月，从社区牙科诊所招募符合国际龋病检测与评估系统代码 5 或 6 标准的儿童，参与一项开放性、平行组、随机临床试验。参与者被随机分配到三个小组中的一个，使用三个方案之一，方案分别是：间隔一个月、四个月或六个月。参与者在头两次就诊时接受 38% SDF 和 5% 氟化钠漆（NaFV）的应用，以治疗已发生龋坏的病变。对病变进行随访并计算其阻滞率。如果病变探诊时质地坚硬且呈黑色，则认为其被阻滞。统计分析包括描述性和双变量分析（Kruskal 单向方差分析和 Pearson's Chi-squared 检验）。p 值≤0.05 被认为具有统计学意义。
84 名儿童参与了本研究（男性 49 名，女性 35 名，平均年龄：44.4±14.2 个月）。每个治疗组有 28 名参与者，治疗组之间匹配良好。共对 374 颗牙齿和 505 个病变进行了随访。后牙病变仅占受累表面的 40.6%。在最后一次随访时，所有 SDF 治疗的病变在一个月（192/196，98%）和四个月（159/166，95.8%）间隔组中几乎都被阻滞。六个月间隔组的阻滞率最低；只有 72%（103/143）的病变被阻滞（p<0.001）。应用间隔时间的长短与所有病变的阻滞率改善呈反比关系。
一个月和四个月间隔期内应用两次 38% SDF 和 5% NaFV 在阻止 ECC 方面效果相当且非常有效。六个月间隔期的应用效果较差，可视为较差的治疗方法。
ClinicalTrials.gov NCT04054635（首次注册于 2019 年 8 月 13 日）。
