纳米氟化银和银氨络合物在抑制儿童早期龋中的效果：一项随机对照临床试验。
Effectiveness of nanosilver fluoride and silver diamine fluoride in arresting early childhood caries: a randomized controlled clinical trial.
机构信息
Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Alexandria University, Champolion St, 21527, Azarita, Alexandria, Egypt.
Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt.
出版信息
BMC Oral Health. 2024 Jun 18;24(1):701. doi: 10.1186/s12903-024-04406-3.
BACKGROUND
One of the most prevalent health problems affecting children worldwide is untreated caries in primary teeth. Agents to arrest caries are used to manage untreated decay in children in disadvantaged communities. Nano Silver Fluoride (NSF) overcomes the staining problems of Silver Diamine Fluoride (SDF). This study compared the clinical cariostatic effect of NSF to 38% SDF for arresting caries lesions.
METHODS
The study included 360 children younger than 4 years, with at least one active lesion, ICDAS score ≥ 3, recruited from nurseries in a rural area in Alexandria, Egypt, in 2022. They were randomly assigned to receive a single application of NSF at baseline, or two applications of SDF at baseline and after 6 months. The arrest of active carious lesions was assessed after 6 and 12 months using ICDAS criteria, and parents' satisfaction with child appearance was also assessed. Chi-Square test was used to compare the groups and multi-level multiple logistic regression was used to assess the effect of the intervention on caries arrest at lesion level and binary logistic regression was used to assess the effect at patient level.
RESULTS
1853 active lesions were included in children whose mean (SD) age was 42.3 (8.2) months. The arrest rate was significantly higher in the NSF than the SDF group at lesion level (78.4% and 65.0% at 6 months and 71.3% and 56.3% at 12 months, p < 0.001). In regression analysis, NSF had significantly higher odds of caries arrest than SDF at lesion level (at 6 months, AOR = 2.57, 95% CI: 1.55, 4.26 and at 12 month, AOR = 3.27, 95% CI: 1.89, 5.67). Parents of children receiving NSF had significantly greater satisfaction with their children's dental appearance than those receiving SDF: (97.2% and 76.1%, respectively, p < 0.001).
CONCLUSION
NSF demonstrated greater effectiveness in arresting caries in preschool children without inducing black staining of teeth and with greater parental satisfaction than SDF. NSF can be an alternative to SDF in arresting caries especially in underprivileged communities.
TRIAL REGISTRATION
The trial was registered in the clinicaltrials.gov registry (#NCT05255913)-16/02/2022.
背景
全球范围内，最普遍的儿童健康问题之一是未治疗的乳牙龋齿。用于控制儿童龋病的药物用于管理贫困社区中未经治疗的儿童龋齿。纳米银氟化物 (NSF) 克服了银胺氟化氢 (SDF) 的染色问题。本研究比较了 NSF 与 38% SDF 对抑制龋病病变的临床抗龋效果。
方法
本研究纳入了 2022 年在埃及亚历山大农村地区幼儿园招募的 360 名年龄小于 4 岁、至少有一个活跃病变、ICDAS 评分≥3 的儿童。他们被随机分配在基线时接受单次 NSF 治疗，或在基线和 6 个月后接受两次 SDF 治疗。在 6 个月和 12 个月时，使用 ICDAS 标准评估活跃龋病病变的抑制情况，并评估父母对儿童外观的满意度。卡方检验用于比较两组，多水平多项逻辑回归用于评估干预对病变水平的龋齿抑制效果，二项逻辑回归用于评估患者水平的效果。
结果
共有 1853 个活跃病变纳入儿童，其平均（标准差）年龄为 42.3（8.2）个月。在病变水平上，NSF 组的抑制率显著高于 SDF 组（6 个月时分别为 78.4%和 65.0%，12 个月时分别为 71.3%和 56.3%，p<0.001）。在回归分析中，NSF 抑制龋病的可能性显著高于 SDF（6 个月时，OR=2.57，95%CI：1.55，4.26；12 个月时，OR=3.27，95%CI：1.89，5.67）。接受 NSF 治疗的儿童的父母对孩子的牙齿外观满意度显著高于接受 SDF 治疗的儿童（分别为 97.2%和 76.1%，p<0.001）。
结论
NSF 在不引起牙齿染色的情况下，对学龄前儿童的龋齿具有更大的抑制作用，并能提高父母的满意度，其效果优于 SDF。NSF 可作为 SDF 的替代品，用于抑制龋齿，特别是在贫困社区。
试验注册
该试验在 clinicaltrials.gov 注册 (#NCT05255913)-16/02/2022。
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