Universidade Metropolitana de Santos (UNIMES), Santos, São Paulo, Brazil.
Centro Universitário São Camilo, São Paulo, São Paulo, Brazil; Cochrane Brazil Affiliate Center - Rio de Janeiro, Petrópolis, Rio de Janeiro, Brazil; Discipline of Evidence Based Health at Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazil.
J Evid Based Dent Pract. 2020 Dec;20(4):101472. doi: 10.1016/j.jebdp.2020.101472. Epub 2020 Jul 29.
This systematic review and meta-analysis aimed to investigate the effectiveness and safety of ozone therapy for treating dental caries.
We searched for randomized controlled trials (RCTs) in 8 databases, from inception to April 4, 2020 (MEDLINE, EMBASE, CENTRAL, LILACS, Bibliografia Brasileira de Odontologia, ClinicalTrials.gov, WHO, and OpenGrey). Primary outcome measures were antimicrobial effect and adverse events. We used the Cochrane risk of bias tool to evaluate methodological quality of included RCTs and GRADE approach to evaluate the certainty of the evidence. We used the Review Manager software to conduct meta-analyses.
We included 12 RCTs comparing ozone therapy with no ozone, chlorhexidine digluconate, fissure sealants (alone and added to ozone), and fluoride. Considering primary outcomes, ozone therapy showed (a) lower reduction in the bacterial number than chlorhexidine digluconate in children (mean difference [MD]: -5.65 [-9.79 to -1.51]), but no difference was observed in adults (MD: -0.10 [-1.07 to 0.88]); (b) higher reduction in the bacterial number than sealant (MD: 12.60 [3.86-21.34]), but no difference was observed after final excavation (MD: -0.00 [-0.01 to 0.01]). Regarding safety of ozone therapy, results from individual studies presented no adverse events during or after treatment. Most of these results are imprecise and should be interpreted with caution because of clinical and methodological concerns, small sample size, and wide confidence interval, precluding to determine the real effect direction.
Based on a very low certainty of evidence, there is not enough support from published RCTs to recommend the use of ozone for the treatment of dental caries. Well-conducted studies should be encouraged, measuring mainly the antimicrobial effects of ozone therapy at long term and following the recommendations of the CONSORT statement for the reporting of RCTs.
本系统评价和荟萃分析旨在研究臭氧疗法治疗龋齿的有效性和安全性。
我们在 8 个数据库中检索了从建库至 2020 年 4 月 4 日的随机对照试验(RCT),包括 MEDLINE、EMBASE、CENTRAL、LILACS、巴西牙科文献数据库、ClinicalTrials.gov、世界卫生组织和 OpenGrey。主要结局指标为抗菌效果和不良事件。我们使用 Cochrane 偏倚风险工具评估纳入 RCT 的方法学质量,并使用 GRADE 方法评估证据的确定性。我们使用 Review Manager 软件进行荟萃分析。
我们纳入了 12 项比较臭氧疗法与无臭氧、洗必泰葡萄糖酸、窝沟封闭剂(单独使用和添加臭氧)和氟化物的 RCT。考虑主要结局,臭氧疗法在儿童中显示(a)与洗必泰葡萄糖酸相比,细菌数量减少更多(MD:-5.65[-9.79 至-1.51]),但在成人中无差异(MD:-0.10[-1.07 至 0.88]);(b)与窝沟封闭剂相比,细菌数量减少更多(MD:12.60[3.86-21.34]),但最终挖除后无差异(MD:-0.00[-0.01 至 0.01])。关于臭氧疗法的安全性,个别研究结果表明治疗期间和治疗后均无不良反应。由于临床和方法学问题、样本量小和置信区间宽,这些结果大多不精确,应谨慎解释,无法确定实际效果方向。
基于极低确定性证据,现有 RCT 不足以支持使用臭氧治疗龋齿。应鼓励开展良好设计的研究,主要测量臭氧治疗的长期抗菌效果,并遵循 CONSORT 声明报告 RCT。