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氟保护漆与戊二醛治疗牙本质敏感症的随机对照试验、Meta 分析及试验序贯分析

Fluoride varnish versus glutaraldehyde for hypersensitive teeth: a randomized controlled trial, meta-analysis and trial sequential analysis.

机构信息

Department of Oral Health, College of Medicine, Nursing and Health Sciences, Fiji National University, Brown Street, Suva, Fiji.

Department of Pharmacology and Therapeutics, Arabian Gulf University, Manama, Bahrain.

出版信息

Clin Oral Investig. 2019 Jan;23(1):209-220. doi: 10.1007/s00784-018-2428-8. Epub 2018 Apr 2.

Abstract

OBJECTIVE

Reports indicate Gluma and Duraphat are commonly used in-office agents to treat hypersensitive teeth. Considering this, the aim of this paper is to compare Gluma and Duraphat using a randomized controlled trial, meta-analysis collating evidences from previous studies and trial sequential analysis.

MATERIALS AND METHODS

Thirty-eight participants were randomized. Hypersensitivity and visual analog scale (VAS) scores were recorded at baseline, 5 min and 7 days. Oral health-related quality of life (OHIP) questionnaire was administered at baseline and 7 days. Statistical analysis was performed to identify significant differences between the variables. For the meta-analysis, electronic data bases were searched and eligible data was extracted and analysed using RevMan 5.0. Trial sequential analysis was performed using O'Brien-Fleming boundary approach for the primary outcome.

RESULTS

Both agents caused significant reduction in hypersensitivity and VAS score at 5 min and 7 days in the randomized trial with no superiority. The quality of life significantly improved in patients treated with both the agents. Four studies including the present trial in meta-analysis and trial sequential analysis indicated that Gluma produced significant reduction in VAS scores at 7 days.

CONCLUSION

Gluma produces significant reduction in hypersensitivity at 7 days post treatment compared with Duraphat. There is definite lack of evidence on the long-term effect of these agents.

CLINICAL RELEVANCE

This paper provides strong evidence on the use of Gluma for hypersensitive teeth. This also is a way forward to future research on long-term effects, adverse effects and cost-effectiveness studies.

摘要

目的

有报道称,固美和达特肤常用于诊室治疗牙本质敏感。鉴于此,本研究旨在通过随机对照试验、荟萃分析整合先前研究证据,并进行试验序贯分析,比较固美和达特肤的疗效。

材料与方法

共 38 名参与者被随机分组。在基线、5 分钟和 7 天时记录敏感症状和视觉模拟评分(VAS),在基线和 7 天时进行口腔健康相关生活质量(OHIP)问卷调查。采用统计分析方法确定各变量间的差异是否有统计学意义。对荟萃分析,检索电子数据库,提取合格数据,使用 RevMan 5.0 进行分析。采用 O'Brien-Fleming 边界法对主要结局进行试验序贯分析。

结果

两组药物在随机试验中均能显著降低 5 分钟和 7 天时的敏感症状和 VAS 评分,但无优势差异。两种药物治疗后患者的生活质量均显著改善。四项研究(包括本研究)进行荟萃分析和试验序贯分析的结果均表明,固美在 7 天时能显著降低 VAS 评分。

结论

与达特肤相比,固美治疗后 7 天牙本质敏感的缓解更显著。这些药物的长期疗效缺乏明确证据。

临床意义

本研究为固美治疗牙本质敏感提供了有力证据。这也为未来进行长期效果、不良反应和成本效益研究指明了方向。

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