Kashbour Wafa, Gupta Puneet, Worthington Helen V, Boyers Dwayne
Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Public Health Dentistry, Government College of Dentistry, Indore, India.
Cochrane Database Syst Rev. 2020 Nov 4;11(11):CD003067. doi: 10.1002/14651858.CD003067.pub5.
Most of the detected increment in dental caries among children above the age of six years and adolescents is confined to occlusal surfaces of posterior permanent molars. Dental sealants and fluoride varnishes are much used to prevent caries. As the effectiveness of both interventions in controlling caries as compared with no intervention has been demonstrated previously, this review aimed to evaluate their relative effectiveness. It updates a review published originally in 2006 and updated in 2010 and in 2016.
Our primary objective was to evaluate the relative effectiveness of dental sealants (i.e. fissure sealant) compared with fluoride varnishes, or fissure sealants plus fluoride varnishes compared with fluoride varnishes alone, for preventing dental caries in the occlusal surfaces of permanent teeth of children and adolescents. Our secondary objectives were to evaluate whether effectiveness is influenced by sealant material type and length of follow-up, document and report on data concerning adverse events associated with sealants and fluoride varnishes, and report the cost effectiveness of dental sealants versus fluoride varnish in caries prevention.
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 19 March 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 2), MEDLINE Ovid (1946 to 19 March 2020) and Embase Ovid (1980 to 19 March 2020). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on the language or date of publication.
We included randomised controlled trials with at least 12 months of follow-up comparing fissure sealants, or fissure sealants plus fluoride varnishes, versus fluoride varnishes, for preventing caries in the occlusal surfaces of permanent posterior teeth (i.e. premolar or molar teeth), in participants younger than 20 years of age at the start of the study.
At least two review authors independently screened search results, extracted data from included studies and assessed their risk of bias. We attempted to contact study authors to obtain missing or unclear information. We grouped and analysed studies on the basis of sealant material type: resin-based sealant or glass ionomer-based sealant (glass ionomer and resin-modified glass ionomer sealant), and different follow-up periods. We calculated the odds ratio (OR) for risk of caries on occlusal surfaces of permanent molar teeth. For trials with a split-mouth design, we used the Becker-Balagtas OR. One cluster-randomised trial provided precise estimates in terms of risk ratio (RR), which we used. For continuous outcomes and data, we used means and standard deviations to obtain mean differences (MD). For meta-analysis, we used the random-effects model when we combined data from four or more studies. We presented all measures with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria.
We included 11 trials with 3374 participants aged five to 10 years when trials started. Three trials are new since the 2016 update. Two trials did not contribute data to our analysis. Sealant versus fluoride varnish Resin-based fissure sealants versus fluoride varnishes Seven trials evaluated this comparison (five contributing data). We are uncertain if resin-based sealants may be better than fluoride varnish, or vice versa, for preventing caries in first permanent molars at two to three years' follow-up (OR 0.67, 95% CI 0.37 to 1.19; I = 84%; 4 studies, 1683 children evaluated). One study measuring decayed, missing and filled permanent surfaces (DMFS) and decayed, missing and filled permanent teeth (DMFT) increment at two years suggested a small benefit for fissure sealant (DMFS MD -0.09, 95% CI -0.15 to -0.03; DMFT MD -0.08, 95% CI -0.14 to -0.02; 542 participants), though this may not be clinically significant. One small study, at high risk of bias, reported a benefit for sealant after four years in preventing caries (RR 0.42, 95% CI 0.21 to 0.84; 75 children) and at nine years (RR 0.48, 95% CI 0.29 to 0.79; 75 children). We assessed each of these results as having very low certainty. Glass ionomer-based sealants versus fluoride varnishes Three trials evaluated this comparison: one trial with chemically cured glass ionomer and two with resin-modified glass ionomer. Studies were clinically diverse, so we did not conduct a meta-analysis. In general, the studies found no benefit of one intervention over another at one, two and three years, although one study, which also included oral health education, suggested a benefit from sealants over varnish for children at high risk of caries. We assessed this evidence as very low certainty. Sealant plus fluoride varnish versus fluoride varnish alone One split-mouth trial analysing 92 children at two-year follow-up found in favour of resin-based fissure sealant plus fluoride varnish over fluoride varnish only (OR 0.30, 95% CI 0.17 to 0.55), which represented a clinically meaningful effect of a 77% reduction in caries after two years; however, we assessed this evidence as very low certainty. Adverse events Five trials (1801 participants) (four using resin-based sealant material and one using resin-modified glass ionomer) reported that no adverse events resulted from use of sealants or fluoride varnishes over one to nine years. The other studies did not mention adverse events.
AUTHORS' CONCLUSIONS: Applying fluoride varnish or resin-based fissure sealants to first permanent molars helps prevent occlusal caries, but it has not been possible in this review to reach reliable conclusions about which one is better to apply. The available studies do not suggest either intervention is superior, but we assessed this evidence as having very low certainty. We found very low-certainty evidence that placing resin-based sealant as well as applying fluoride varnish works better than applying fluoride varnish alone. Fourteen studies are currently ongoing and their findings may allow us to draw firmer conclusions about whether sealants and varnish work equally well or whether one is better than the other.
在6岁以上儿童和青少年中,大多数检测到的龋齿增加仅限于恒牙后磨牙的咬合面。牙科密封剂和氟化物清漆常用于预防龋齿。由于先前已证明这两种干预措施与不干预相比在控制龋齿方面的有效性,本综述旨在评估它们的相对有效性。它更新了最初于2006年发表、并于2010年和2016年更新的一篇综述。
我们的主要目的是评估牙科密封剂(即窝沟封闭剂)与氟化物清漆相比,或窝沟封闭剂加氟化物清漆与单独使用氟化物清漆相比,在预防儿童和青少年恒牙咬合面龋齿方面的相对有效性。我们的次要目的是评估有效性是否受密封剂材料类型和随访时间的影响,记录并报告与密封剂和氟化物清漆相关的不良事件数据,并报告牙科密封剂与氟化物清漆在预防龋齿方面的成本效益。
Cochrane口腔健康信息专家检索了以下数据库:Cochrane口腔健康试验注册库(截至2020年3月19日)、Cochrane对照试验中央注册库(CENTRAL)(Cochrane图书馆,2020年第2期)、MEDLINE Ovid(1946年至2020年3月19日)和Embase Ovid(1980年至2020年3月19日)。我们检索了美国国立卫生研究院试验注册库(ClinicalTrials.gov)和世界卫生组织国际临床试验注册平台,以查找正在进行的试验。对发表语言或日期没有限制。
我们纳入了至少随访12个月的随机对照试验,这些试验比较了窝沟封闭剂,或窝沟封闭剂加氟化物清漆,与氟化物清漆,用于预防研究开始时年龄小于20岁的参与者恒牙后磨牙(即前磨牙或磨牙)咬合面的龋齿。
至少两名综述作者独立筛选检索结果,从纳入的研究中提取数据并评估其偏倚风险。我们试图联系研究作者以获取缺失或不清楚的信息。我们根据密封剂材料类型(树脂基密封剂或玻璃离子基密封剂(玻璃离子和树脂改性玻璃离子密封剂))以及不同的随访期对研究进行分组和分析。我们计算了恒牙磨牙咬合面龋齿风险的比值比(OR)。对于采用分口设计的试验,我们使用Becker-Balagtas OR。一项整群随机试验提供了风险比(RR)方面的精确估计值,我们采用了该值。对于连续结局和数据,我们使用均值和标准差来获得均值差(MD)。对于荟萃分析,当我们合并四项或更多研究的数据时,使用随机效应模型。我们给出了所有测量值的95%置信区间(CI)。我们使用GRADE标准评估证据的确定性。
我们纳入了11项试验,试验开始时参与者年龄在5至10岁之间,共3374人。自2016年更新以来有3项新试验。两项试验未为我们的分析提供数据。密封剂与氟化物清漆 树脂基窝沟封闭剂与氟化物清漆 七项试验评估了这一比较(五项提供了数据)。我们不确定在随访两到三年时,树脂基密封剂在预防第一恒磨牙龋齿方面是否可能优于氟化物清漆,反之亦然(OR 0.67,95%CI 0.37至1.19;I² = 84%;4项研究,1683名儿童接受评估)。一项在两年时测量龋失补牙面(DMFS)和龋失补牙数(DMFT)增量的研究表明窝沟封闭剂有小的益处(DMFS MD -0.09,95%CI -0.15至-0.03;DMFT MD -0.08,95%CI -0.14至-;542名参与者),尽管这可能无临床意义。一项存在高偏倚风险的小型研究报告称,在四年时密封剂在预防龋齿方面有益处(RR 0.42,95%CI 0.21至0.84;75名儿童),在九年时也有益处(RR 0.48,95%CI 0.29至0.79;75名儿童)。我们将这些结果中的每一个评估为具有极低的确定性。玻璃离子基密封剂与氟化物清漆 三项试验评估了这一比较:一项试验使用化学固化玻璃离子,两项试验使用树脂改性玻璃离子。研究在临床上具有多样性,因此我们未进行荟萃分析。总体而言,这些研究发现在一年、两年和三年时,一种干预措施并不比另一种更有益处,尽管一项还包括口腔健康教育的研究表明,对于高龋齿风险儿童,密封剂比清漆更有益处。我们将此证据评估为具有极低的确定性。密封剂加氟化物清漆与单独使用氟化物清漆 一项分口试验在两年随访时分析了92名儿童,发现树脂基窝沟封闭剂加氟化物清漆优于仅使用氟化物清漆(OR 0.30,95%CI 0.17至0.55),这代表了两年后龋齿减少77%的具有临床意义的效果;然而,我们将此证据评估为具有极低的确定性。不良事件 五项试验(1801名参与者)(四项使用树脂基密封剂材料,一项使用树脂改性玻璃离子)报告称,在一到九年的时间里,使用密封剂或氟化物清漆未导致不良事件。其他研究未提及不良事件。
在第一恒磨牙上应用氟化物清漆或树脂基窝沟封闭剂有助于预防咬合面龋齿,但在本综述中,无法就哪种应用方式更好得出可靠结论。现有研究未表明哪种干预措施更优越,但我们将此证据评估为具有极低的确定性。我们发现具有极低确定性的证据表明,放置树脂基密封剂以及应用氟化物清漆比仅应用氟化物清漆效果更好。目前有14项研究正在进行,它们的结果可能使我们能够就密封剂和清漆的效果是否相同或哪种更好得出更确凿的结论。