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本文引用的文献

1
Short- and long term antibacterial effects of a single rinse with different mouthwashes: A randomized clinical trial.单次使用不同漱口水的短期和长期抗菌效果：一项随机临床试验。
Heliyon. 2023 Apr 6;9(4):e15350. doi: 10.1016/j.heliyon.2023.e15350. eCollection 2023 Apr.
2
Daily use of chlorine dioxide effectively treats halitosis: A meta-analysis of randomised controlled trials.二氧化氯的日常使用可有效治疗口臭：一项随机对照试验的荟萃分析。
PLoS One. 2023 Jan 12;18(1):e0280377. doi: 10.1371/journal.pone.0280377. eCollection 2023.
3
Could polyhexanide and chlorine dioxide be used as an alternative to chlorhexidine? A systematic review.聚己二胍和二氧化氯可否替代洗必泰？系统评价。
Sao Paulo Med J. 2022 Jan-Feb;140(1):42-55. doi: 10.1590/1516-3180.2020.0776.R1.18052021.
4
The association between halitosis and oral-health-related quality of life: A systematic review and meta-analysis.口臭与口腔健康相关生活质量的关系：系统评价和荟萃分析。
J Clin Periodontol. 2021 Nov;48(11):1458-1469. doi: 10.1111/jcpe.13530. Epub 2021 Sep 6.
5
A randomized, blinded, clinical investigation of breath odor reduction efficacy of a stabilized chlorine-dioxide containing flavored mouthwash.一种含稳定二氧化氯的调味漱口水减少口气功效的随机、双盲、临床研究。
Am J Dent. 2021 Aug;34(4):195-200.
6
Alternative therapies in controlling oral malodour: a systematic review.替代疗法控制口腔异味：系统评价。
J Breath Res. 2021 Jan 22;15(2). doi: 10.1088/1752-7163/abcd2b.
7
Comparative study of hyperpure chlorine dioxide with two other irrigants regarding the viability of periodontal ligament stem cells.高纯度二氧化氯与另外两种冲洗液对牙周膜干细胞活力影响的对比研究。
Clin Oral Investig. 2021 May;25(5):2981-2992. doi: 10.1007/s00784-020-03618-5. Epub 2020 Oct 12.
8
Interventions for managing halitosis.口臭管理干预措施。
Cochrane Database Syst Rev. 2019 Dec 11;12(12):CD012213. doi: 10.1002/14651858.CD012213.pub2.
9
Efficacy of stabilized chlorine dioxide-based unflavored mouthwash in reducing oral malodor: An 8-week randomized controlled study.基于稳定二氧化氯的无味漱口水减少口腔异味的疗效：一项为期8周的随机对照研究。
Am J Dent. 2018 Dec;31(6):309-312.
10
Effectiveness of Different Commercial Chlorhexidine-Based Mouthwashes After Periodontal and Implant Surgery: A Systematic Review.不同商业化氯己定基漱口液在牙周及种植术后的效果：系统评价。
Implant Dent. 2019 Feb;28(1):74-85. doi: 10.1097/ID.0000000000000854.

高纯度二氧化氯与氯己定治疗口腔口臭的比较（ODOR试验）——一项双盲、双臂、平行非劣效性先导随机对照试验方案

Hyperpure chlorine dioxide versus chlorhexidine in intra-oral halitosis (ODOR trial) - protocol of a double-blinded, double-arm, parallel non-inferiority pilot randomized controlled trial.

作者信息

Szalai Eszter Ágnes, Teutsch Brigitta, Babay Viktória, Galvács Adél, Hegyi Péter, Hársfalvi Péter, Pál Róbert, Varga Gábor, Lohinai Zsolt M, Kerémi Beáta

机构信息

Department of Restorative Dentistry and Endodontics, Semmelweis University, Budapest, Hungary.

Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.

出版信息

BDJ Open. 2024 May 20;10(1):35. doi: 10.1038/s41405-024-00221-8.

DOI:10.1038/s41405-024-00221-8
PMID:38769314
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11106080/
Abstract

INTRODUCTION

Intra-oral halitosis (IOH) is the most common type of bad breath; its consequences impair quality of life. However, evidence-based treatment protocols and guidelines are lacking. Our aim is to investigate the effectiveness of chlorine dioxide as an applicable complementary treatment modality in IOH after tongue cleaning.

METHODS AND ANALYSIS

The ODOR trial will be a single-center, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. We plan to investigate the short-term effects of the intervention over a 3-h period. The primary endpoint will be changes in organoleptic test scores. At the end of the pilot investigation of the first 30 patients each, sample size calculation will be performed. If feasible, the investigators will continue the study by enrolling more patients.

TRIAL REGISTRATION

The trial has been registered at ClinicalTrials.gov (NCT06219226).

摘要

引言

口腔内口臭（IOH）是最常见的口臭类型；其后果会损害生活质量。然而，缺乏基于证据的治疗方案和指南。我们的目的是研究二氧化氯作为舌清洁后IOH适用的辅助治疗方式的有效性。

方法与分析

ODOR试验将是一项单中心、双盲、平行组、双臂先导随机对照试验，采用非劣效性设计。将超纯二氧化氯的疗效与洗必泰漱口水进行比较。我们计划在3小时内研究干预措施的短期效果。主要终点将是感官测试分数的变化。在对每组前30名患者进行先导研究结束时，将进行样本量计算。如果可行，研究人员将通过招募更多患者继续该研究。

试验注册

该试验已在ClinicalTrials.gov（NCT06219226）注册。