An open-label, parallel-group, randomized clinical trial of different silver diamine fluoride application intervals to arrest dental caries

Robert J Schroth, Sukeerat Bajwa, Victor H K Lee, Betty-Anne Mittermuller, Sarbjeet Singh, Vivianne Cruz de Jesus, Mary Bertone, Prashen Chelikani
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Abstract

Background: Non-surgical interventions are preferred to address the widespread issue of early childhood caries (ECC). 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 ECC at three different application regimen intervals. Methods: Children with ECC were recruited from community dental clinics into an open-label, parallel-group, randomized clinical trial. Participants were randomized to one of three groups: 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. A p-value of ≤ 0.05 was considered significant. Results: 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 29.1% of affected surfaces. Almost all SDF treated lesions were arrested for the one-month (98%) and four-month (95.8%) interval groups at the final visit. The six-month group experienced the lowest arrest rates; only 72% of lesions were arrested (p < 0.001). The duration of application intervals was inversely associated with improvements in arrest rates for all lesions.
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一项开放标签、平行分组、随机临床试验:不同的二胺二银氟化物涂抹间隔时间对抑制龋齿的作用
背景:要解决普遍存在的儿童早期龋齿(ECC)问题,非手术干预是首选。二胺氟化银(SDF)是一种抗菌剂,也是一种可用于抑制蛀牙的替代治疗方法。虽然人们对 SDF 的龋齿治疗效果持乐观态度,但对于儿童使用 SDF 的次数和频率却没有达成真正的共识。本研究的目的是考察 38% SDF 在三种不同的使用间隔下抑制 ECC 的效果:方法:从社区牙科诊所招募患有 ECC 的儿童参加一项开放标签、平行组、随机临床试验。参与者被随机分为三组:分别间隔一个月、四个月或六个月就诊。参与者在前两次就诊时接受 38% SDF 和 5% 氟化钠清漆 (NaFV) 的涂抹,以治疗龋齿病变。对病变进行跟踪,并计算龋坏率。如果病变在探诊时变硬且颜色变黑,则视为龋坏。统计包括描述性分析和双变量分析。结果:84名儿童参与了研究(49名男性和35名女性,平均年龄:44.4 ± 14.2个月)。每组 28 人,治疗组匹配良好。共跟踪了 374 颗牙齿和 505 个病变部位。后部病变仅占受影响表面的 29.1%。在最后一次就诊时,间隔一个月(98%)和四个月(95.8%)的治疗组中,几乎所有经 SDF 治疗的病变都得到了控制。间隔六个月组的病灶切除率最低,只有 72% 的病灶切除(p <0.001)。应用间隔时间的长短与所有病变的抑制率的提高成反比。
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