Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.
Faculty of Dentistry, The University of Hong Kong, Hong Kong, China; Department of Stomatology, School of Medicine, Xiamen University, Xiamen, China.
Int Dent J. 2023 Oct;73(5):667-673. doi: 10.1016/j.identj.2022.12.005. Epub 2023 Jan 20.
This clinical trial aimed to compare the caries-preventive effect of annual application of 38% silver diamine fluoride solution (SDF) with 5% sodium fluoride varnish (FV) to the anterior primary teeth of children. The hypothesis was that SDF was superior to FV at 1 year. Secondary objectives were to determine the child's cooperation and the parent's satisfaction and assess adverse effects.
We recruited 688 3- to 4-year-old children and randomly allocated them to receive SDF or FV (positive control) on their 6 upper anterior teeth. Tooth-surface status was recorded using the decayed, missing, and filled surfaces index. A trained observer rated the child's cooperation as "totally cooperative" or "not totally cooperative." We used a questionnaire to determine the parent's satisfaction as "satisfied," "neutral," or "dissatisfied." Adverse effects (yes/no) were evaluated 1 day and about 1 year after treatment.
Of the children, 434 (SDF, n = 209; FV, n = 225) completed the trial. The mean new decayed tooth surfaces developed for SDF and FV groups were 0.4 ± 1.5 and 0.4 ± 1.3, respectively (P = .65). Child's cooperation for SDF and FV therapy was 71% (244/344) and 70% (241/344), respectively (P = .89). Parent's satisfaction for SDF and FV therapy was 71% (148/209) and 69% (155/225), respectively (P = .29). Adverse effects were found neither at 1 day nor at about 1 year after treatment for either treatment arm.
SDF is not superior to FV for caries prevention in primary upper anterior teeth at 1-year follow-up. Child's cooperation and parent's satisfaction were similarly high with SDF and FV therapy at 1-year follow-up. Neither short-term nor long-term adverse effects were observed. This study is registered at ClinicalTrials.gov (NCT04399369).
本临床试验旨在比较每年应用 38% 氟化银（SDF）溶液和 5%氟化钠（FV）对儿童前牙龋齿的预防效果。假设 SDF 在 1 年时优于 FV。次要目标是确定儿童的合作情况和家长的满意度，并评估不良反应。
我们招募了 688 名 3 至 4 岁的儿童，并将其随机分为 SDF 组或 FV 组（阳性对照组），在前 6 颗上颌前牙上进行治疗。使用龋失补牙面指数记录牙面状况。一名经过培训的观察者将儿童的合作情况评为“完全合作”或“不完全合作”。我们使用问卷来确定家长的满意度为“满意”、“中立”或“不满意”。治疗后 1 天和大约 1 年后评估不良反应（是/否）。
在这些儿童中，434 名（SDF 组，n=209；FV 组，n=225）完成了试验。SDF 和 FV 组新发生的龋齿表面平均分别为 0.4±1.5 和 0.4±1.3（P=0.65）。SDF 和 FV 治疗的儿童合作率分别为 71%（244/344）和 70%（241/344）（P=0.89）。SDF 和 FV 治疗的家长满意度分别为 71%（148/209）和 69%（155/225）（P=0.29）。两种治疗方法在治疗后 1 天和大约 1 年时均未发现不良反应。
在 1 年随访时，SDF 在预防上前牙龋齿方面并不优于 FV。在 1 年随访时，SDF 和 FV 治疗的儿童合作情况和家长满意度相似。未观察到短期或长期不良反应。本研究在 ClinicalTrials.gov（NCT04399369）注册。
