Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Department of Epidemiology and Health Promotion, New York University College of Dentistry, New York, USA.
Cochrane Database Syst Rev. 2024 Nov 7;11(11):CD012718. doi: 10.1002/14651858.CD012718.pub2.
Dental caries is the world's most prevalent disease. Untreated caries can cause pain and negatively impact psychosocial health, functioning, and nutrition. It is important to identify cost-effective, easy-to-use agents, which can prevent or arrest caries. This review evaluates silver diamine fluoride (SDF).
To assess the effects of silver diamine fluoride for preventing and managing caries in primary and permanent teeth (coronal and root caries) compared to any other intervention including placebo or no treatment.
We searched CENTRAL, MEDLINE, Embase, Cochrane Oral Health's Trial Register and two clinical trials registers in June 2023.
We included randomised controlled trials (RCTs), with parallel-group or split-mouth design, in children and adults (with or without carious lesions) that compared SDF with placebo or no treatment; different frequencies, concentrations or duration of SDF; or any other intervention.
We used standard methodological procedures expected by Cochrane, and GRADE to assess the certainty of the evidence. We collected data for primary caries prevention (change in caries increment), arrest of carious lesions, secondary prevention of caries (lesions do not progress from initial classification), adverse effects, dental pain or sensitivity, and aesthetics at the end of study follow-up.
We included 29 RCTs (13,036 participants; 12,020 children, 1016 older adults). We summarise outcome data for the five most clinically relevant comparisons. All studies included high risks of bias, and some findings were imprecise (e.g. because of small sample sizes). SDF versus placebo or no treatment (14 studies; 2695 children, 905 older adults) Compared to placebo or no treatment, SDF may help prevent new caries in the primary dentition (1 study, 373 participants), or on the coronal surfaces of permanent dentition (1 study, 373 participants) but the evidence is very uncertain. SDF likely prevents new root caries (mean difference (MD) -0.79 surfaces, 95% confidence interval (CI) -1.40 to -0.17; 3 studies, 439 participants; moderate-certainty evidence). SDF may help arrest caries in the primary dentition (MD 0.86 surfaces, 95% CI 0.39 to 1.33; 2 studies, 841 participants; low-certainty evidence) and the permanent dentition (coronal: 1 study, 373 participants; root: 1 study, 158 participants) but the evidence is very uncertain. The evidence is very uncertain for secondary prevention of caries (primary dentition: 1 study, 128 participants; permanent dentition (coronal): 1 study, 663 participants), for adverse effects (5 studies, 1299 participants), and aesthetics (1 study, 43 participants). Different approaches to SDF application (5 studies, 1808 children) Studies compared different frequencies or intervals of application, different concentrations of SDF, and different durations of treatment. Some studies included multiple comparisons of different approaches. Because of the different approaches, we could not combine findings from these studies. Due to very low-certainty evidence, we were unsure whether any approach to SDF application was better than another for caries arrest (4 studies, including 8 comparisons of different approaches, 1360 participants); secondary prevention of caries (1 study, 203 participants), or led to differences in adverse effects (3 studies, 1121 children) or aesthetics (1 study, 119 children). SDF versus fluoride varnish (8 studies, 2868 children, 223 older adults) Compared to flouride varnish, SDF may result in little or no difference to the prevention of new caries in the primary dentition (MD 0.00, 95% CI -0.26 to 0.26; 1 study, 434 participants; low-certainty evidence). The evidence is very uncertain for this outcome measure in the permanent dentition (coronal: 1 study, 237 participants; root: 1 study, 100 participants; very low-certainty evidence). Due to very low-certainty evidence, we were unsure whether or not there were any differences between flouride varnish (applied weekly for three applications) and SDF for caries arrest and secondary prevention of caries in the primary dentition (1 study, 309 participants). Similarly, we were unsure of adverse effects (3 studies, 980 children), dental pain or sensitivity (1 study, 62 children), or aesthetics (1 study, 263 children). SDF versus sealants and resin infiltration (2 studies, 343 children) Very low-certainty evidence in this comparison meant we were unsure if either treatment was better than the other for primary prevention of caries in permanent dentition (coronal: 1 study, 242 participants), or adverse effects (2 studies, 336 participants). SDF versus atraumatic restorative treatment (ART) with glass ionomer cement (GIC) or GI material (4 studies, 610 children) Very low-certainty evidence in this comparison meant we were unsure if either treatment was better than the other at arresting caries in the primary dentition (1 study, 143 participants). We were also unsure whether there were any differences between treatments in adverse effects (3 studies, 482 participants), dental pain or sensitivity (1 study, 234 participants), or aesthetics (2 studies, 248 participants).
AUTHORS' CONCLUSIONS: In the primary dentition, evidence remains uncertain whether SDF prevents new caries or progression of existing caries compared to placebo or no treatment, but it may offer benefit over placebo or no treatment in caries arrest. Compared to placebo or no treatment, SDF probably also helps prevent new root caries. However, the evidence is uncertain for other caries outcome measures in this dentition and in all caries outcomes for coronal surfaces of permanent dentition. Compared to flouride varnish, SDF may offer little or no benefit in preventing new caries in the primary dentition, but the evidence is very uncertain for other caries outcome measures in the primary dentition and for preventing new caries in the permanent dentition. We were unable to establish whether one SDF treatment approach was better than another, or how SDF compared to other treatments, because of very low-certainty evidence. The impact of SDF staining of teeth was poorly reported and the evidence for adverse effects is very uncertain. Additional well-conducted studies are needed. These should measure the impact of staining and be analysed to take account of clustering issues within participants.
龋齿是世界上最普遍的疾病。未经治疗的龋齿会引起疼痛,并对社会心理健康、功能和营养产生负面影响。识别既经济实惠又易于使用的药物,以预防或控制龋齿是很重要的。本综述评估了银胺氟化物(SDF)。
评估在乳牙和恒牙(冠部和根部龋齿)中使用 SDF 预防和治疗龋齿与任何其他干预措施(包括安慰剂或不治疗)的效果。
我们于 2023 年 6 月在 Cochrane 中心、MEDLINE、Embase、Cochrane 口腔健康试验登记册和两个临床试验登记册中检索了随机对照试验(RCT)。
我们纳入了随机对照试验(RCT),采用平行组或劈裂设计,纳入了儿童和成人(有或无龋齿病变)的 SDF 与安慰剂或不治疗;SDF 的不同频率、浓度或持续时间;或任何其他干预措施。
我们使用了 Cochrane 预期的标准方法学程序,并使用 GRADE 评估证据的确定性。我们在研究随访结束时收集了初级龋齿预防(龋齿增量变化)、龋齿病变的控制、龋齿的二级预防(病变不会从初始分类进展)、不良反应、牙齿疼痛或敏感性以及美学的相关数据。
我们纳入了 29 项 RCT(13036 名参与者;12020 名儿童,1016 名老年人)。我们总结了五个最具临床相关性的比较的结果数据。所有研究都存在高偏倚风险,并且一些发现存在不准确性(例如,由于样本量小)。SDF 与安慰剂或不治疗(14 项研究;2695 名儿童,905 名老年人)与安慰剂或不治疗相比,SDF 可能有助于预防乳牙的新发龋齿(1 项研究,373 名参与者),或预防恒牙的冠部龋齿(1 项研究,373 名参与者),但证据非常不确定。SDF 可能有助于预防新的根面龋(平均差值(MD)-0.79 个面,95%置信区间(CI)-1.40 至-0.17;3 项研究,439 名参与者;中等确定性证据)。SDF 可能有助于控制乳牙的龋齿(MD 0.86 个面,95%CI 0.39 至 1.33;2 项研究,841 名参与者;低确定性证据)和恒牙的龋齿(冠部:1 项研究,373 名参与者;根部:1 项研究,158 名参与者),但证据非常不确定。龋齿的二级预防(乳牙:1 项研究,128 名参与者;恒牙(冠部):1 项研究,663 名参与者)、不良反应(5 项研究,1299 名参与者)和美学(1 项研究,43 名参与者)的证据非常不确定。SDF 应用方法的不同(5 项研究,1808 名儿童)这些研究比较了不同的应用频率或间隔、不同的 SDF 浓度和不同的治疗持续时间。一些研究包括了对不同方法的多次比较。由于不同的方法,我们无法合并这些研究的结果。由于低确定性证据,我们不确定任何一种 SDF 应用方法是否优于另一种方法在龋齿控制(4 项研究,包括 8 种不同方法的比较,1360 名参与者)、龋齿的二级预防(1 项研究,203 名参与者)或导致不良反应(3 项研究,1121 名儿童)或美学(1 项研究,119 名儿童)方面的差异。SDF 与氟化物漆(8 项研究,2868 名儿童,223 名老年人)与氟化物漆相比,SDF 可能对预防乳牙的新发龋齿没有或几乎没有影响(MD 0.00,95%CI-0.26 至 0.26;1 项研究,434 名参与者;低确定性证据)。在恒牙的冠部(1 项研究,237 名参与者;根部:1 项研究,100 名参与者;非常低确定性证据)和根部(1 项研究,100 名参与者;非常低确定性证据),这一结果测量的证据非常不确定。由于低确定性证据,我们不确定氟化物漆(每周应用三次,每次应用三次)和 SDF 之间在乳牙的龋齿控制和二级预防方面是否存在差异(1 项研究,309 名参与者)。同样,我们也不确定不良反应(3 项研究,980 名儿童)、牙齿疼痛或敏感性(1 项研究,62 名儿童)或美学(1 项研究,263 名儿童)方面的差异。SDF 与密封剂和树脂渗透(2 项研究,343 名儿童)这一比较中的低确定性证据意味着,我们不确定哪种治疗方法在恒牙的初级预防中优于另一种方法(冠部:1 项研究,242 名参与者),或不良反应(2 项研究,336 名参与者)。SDF 与玻璃离子水门汀(GIC)或 GI 材料的非创伤性修复治疗(ART)(4 项研究,610 名儿童)这一比较中的低确定性证据意味着,我们不确定在乳牙中,哪种治疗方法在控制龋齿方面优于另一种方法(1 项研究,143 名参与者)。我们也不确定两种治疗方法在不良反应(3 项研究,482 名参与者)、牙齿疼痛或敏感性(1 项研究,234 名参与者)或美学(2 项研究,248 名参与者)方面是否存在差异。
在乳牙中,与安慰剂或不治疗相比,SDF 预防新发龋齿或现有龋齿进展的证据仍不确定,但与安慰剂或不治疗相比,SDF 可能在控制龋齿方面有一定的益处。与安慰剂或不治疗相比,SDF 可能还能预防新的根面龋。然而,在这种牙位和所有恒牙的冠部龋齿的其他龋齿结局指标中,证据仍不确定。与氟化物漆相比,SDF 可能在预防乳牙的新发龋齿方面没有或几乎没有益处,但在乳牙和恒牙的其他龋齿结局指标以及预防恒牙的新发龋齿方面,证据非常不确定。由于低确定性证据,我们无法确定一种 SDF 治疗方法是否优于另一种方法,或 SDF 与其他治疗方法相比如何。由于 SDF 对牙齿染色的影响报告不佳,且不良反应的证据非常不确定,因此需要进行更多的研究。这些研究应测量染色的影响,并分析以考虑参与者内部的聚类问题。