Rasines Graciela
Evidence-based Dentistry Commission, Dental Association of Argentina, Buenos Aires, Argentina.
Evid Based Dent. 2010;11(1):6-7. doi: 10.1038/sj.ebd.6400698.
The Cochrane Oral Health Group's Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE databases were searched. Previously published systematic reviews of fluoride toothpastes were also screened to identify any reports that met the inclusion criteria. In addition, the trials database at www.controlled-trials.com/ and the meta Register of Controlled Trials (www.controlledtrials.com) were searched to identify any ongoing studies of relevance.
Randomised controlled trials (RCT) and cluster-RCT that compared fluoride toothpaste with placebo or fluoride toothpaste of a different concentration in children of up to 16 years of age, with a followup period of at least 1 year, were included.
Inclusion of studies, data extraction and quality assessment were undertaken independently and in duplicate by two members of the review team. Disagreements were resolved by discussion and consensus or by a third party. The primary effect measure was the prevented fraction (PF, the caries increment of the control group minus the caries increment of the treatment group, expressed as a proportion of the caries increment in the control group). Where it was appropriate to pool data, network meta-analysis, network meta-regression or meta-analysis models were used. Potential sources of heterogeneity were specified a priori and examined through random-effects metaregression analysis where appropriate.
From 535 studies found, 75 were included. From these, 71 studies (79 trials) contributed data to the network meta-analysis, network metaregression or meta-analysis. For the 66 studies (74 trials) that contributed to the network meta-analysis of decayed, missing or filled surfaces [D(M)FS] in the mixed or permanent dentition, the caries preventive effect of fluoride toothpaste increased significantly with higher fluoride concentrations, with a D(M)FS PF compared with placebo of 23% [95% credible interval (CrI), 19-27%] for 1000/ 1055/ 1100/ 1250 ppm concentrations, rising to 36% (95% CrI, 27-44%) for toothpastes with a concentration of 2400/ 2500/ 2800 ppm. Concentrations of 440/ 500/ 550 ppm and below showed no statistically significant effect when compared to placebo.There is some evidence of a dose-response relationship in that the PF increased as the fluoride concentration increased from the baseline although this was not always statistically significant. The effect of fluoride toothpaste also increased with baseline level of D(M)FS and supervised brushing, though this did not reach statistical significance. Six studies assessed the effects of fluoride concentrations on the deciduous dentition with equivocal results dependent upon the fluoride concentrations compared and the outcome measure. Compliance with treatment regimen and unwanted effects was assessed in only a minority of studies. When reported, no differential compliance was observed and unwanted effects such as soft tissue damage and tooth staining were minimal.
This review confirms the benefits of using fluoride toothpaste in preventing caries in children and adolescents compared with placebo, but only statistically significantly at fluoride concentrations of 1000 ppm and above. The relative caries preventive effects of fluoride toothpastes of different concentrations increase with higher fluoride concentration. The decision of what fluoride levels to use for children aged under 6 years should be balanced with the risk of fluorosis.
检索了Cochrane口腔健康小组试验注册库、Cochrane对照试验中央注册库、MEDLINE和EMBASE数据库。还筛选了之前发表的关于含氟牙膏的系统评价,以确定符合纳入标准的任何报告。此外,检索了www.controlled-trials.com/的试验数据库和对照试验元注册库(www.controlledtrials.com),以确定任何相关的正在进行的研究。
纳入随机对照试验(RCT)和整群随机对照试验,这些试验比较了含氟牙膏与安慰剂或不同浓度含氟牙膏对16岁及以下儿童的效果,随访期至少1年。
研究的纳入、数据提取和质量评估由两名综述团队成员独立进行且重复操作。分歧通过讨论和协商解决,或由第三方解决。主要效应指标是预防分数(PF,对照组的龋损增加量减去治疗组的龋损增加量,以对照组龋损增加量的比例表示)。在适当合并数据时,使用网络荟萃分析、网络荟萃回归或荟萃分析模型。预先指定潜在的异质性来源,并在适当情况下通过随机效应荟萃回归分析进行检验。
在检索到的535项研究中,75项被纳入。其中,71项研究(79项试验)为网络荟萃分析、网络荟萃回归或荟萃分析提供了数据。对于66项研究(74项试验),这些研究为混合牙列或恒牙列中龋失补牙面数[D(M)FS]的网络荟萃分析提供了数据,含氟牙膏的防龋效果随着氟浓度的升高而显著增加,对于1000/1055/1100/1250 ppm浓度的牙膏,与安慰剂相比,D(M)FS的PF为23%[95%可信区间(CrI),19 - 27%],对于浓度为2400/2500/2800 ppm的牙膏,PF升至36%(95% CrI,27 - 44%)。与安慰剂相比,440/500/550 ppm及以下浓度未显示出统计学显著效果。有一些证据表明存在剂量 - 反应关系,即随着氟浓度从基线升高,PF增加,尽管并非总是具有统计学显著性。含氟牙膏的效果也随着D(M)FS的基线水平和监督刷牙而增加,尽管这未达到统计学显著性。六项研究评估了氟浓度对乳牙列的影响,结果因所比较的氟浓度和结局指标而异。只有少数研究评估了治疗方案的依从性和不良反应。报告时,未观察到依从性差异,软组织损伤和牙齿染色等不良反应很少。
本综述证实,与安慰剂相比,使用含氟牙膏对预防儿童和青少年龋齿有益,但仅在氟浓度为1000 ppm及以上时具有统计学显著性。不同浓度含氟牙膏的相对防龋效果随着氟浓度的升高而增加。对于6岁以下儿童使用何种氟水平的决策应与氟斑牙风险相平衡。