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38%氟化亚锡银治疗中国老年成年人暴露根面牙本质过敏症的疗效:一项随机双盲研究的研究方案

Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults: Study Protocol for a Randomised Double-Blind Study.

作者信息

Chan Alice Kit Ying, Tamrakar Manisha, Jiang Chloe Meng, Tsang Yiu Cheung, Leung Katherine Chiu Man, Chu Chun Hung

机构信息

Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.

出版信息

Dent J (Basel). 2022 Oct 19;10(10):194. doi: 10.3390/dj10100194.

DOI:10.3390/dj10100194
PMID:36286004
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9600009/
Abstract

BACKGROUND

Dentine hypersensitivity on an exposed root surface induces pain, affects daily oral hygiene practice, limits dietary choices and negatively affects quality of life. Silver diamine fluoride is marketed in the United States as a desensitising agent, but well-designed clinical trials are limited. This study evaluates the anti-hypersensitivity effect of silver diamine fluoride on hypersensitive teeth due to an exposed root surface in older Chinese adults.

METHODS/DESIGN: We will conduct a randomised double-blind clinical trial with a sample size of at least 148 Chinese older adults aged 65 or above who have dentine hypersensitivity due to an exposed root surface. We will collect written consent before the study. A trained examiner will examine the participants' teeth with a blast of compressed air from a 3-in-1 syringe. Those adults who report a self-perceived sensitivity score (SS) (0 to 10) of 8 or more on at least one tooth with an exposed root surface will be recruited. The recruited older adults will be randomly allocated into two groups using a block randomisation of six. Group 1 participants will receive the application of 38% silver diamine fluoride solution every 4 weeks. Group 2 participants will receive the application of 5% potassium nitrate solution every 4 weeks. Dietary advice, oral hygiene instruction and fluoride toothpaste at 1450 ppm will be provided to participants in both groups. The same trained examiner will perform follow-up examinations for the participants and determine the dentine hypersensitivity in SS of the most hypersensitive tooth (with the highest pre-treatment SS) immediately after the intervention and at 4-week and 8-week intervals.

DISCUSSION

There is no consensus on the standard of care for a professionally applied desensitising agent in older adults. This trial will provide evidence for clinicians to devise an effective dental care plan for older adults with dentine hypersensitivity.

TRIAL REGISTRATION

NCT05392868 Registered on 22 May 2022.

摘要

背景

暴露牙根表面的牙本质过敏会引发疼痛,影响日常口腔卫生习惯,限制饮食选择,并对生活质量产生负面影响。氟化亚银在美国作为一种脱敏剂销售,但精心设计的临床试验有限。本研究评估氟化亚银对中国老年成年人因牙根表面暴露导致的牙齿过敏的抗过敏效果。

方法/设计:我们将进行一项随机双盲临床试验,样本量至少为148名65岁及以上因牙根表面暴露而患有牙本质过敏的中国老年人。在研究前我们将收集书面同意书。一名经过培训的检查者将使用三合一注射器喷出的压缩空气检查参与者的牙齿。那些在至少一颗有暴露牙根表面的牙齿上自我感觉敏感度评分(SS)(0至10)为8或更高的成年人将被招募。招募的老年人将使用六个一组的区组随机化方法随机分为两组。第1组参与者将每4周接受一次38%氟化亚银溶液的涂抹。第2组参与者将每4周接受一次5%硝酸钾溶液的涂抹。两组参与者都将获得饮食建议、口腔卫生指导以及1450 ppm的含氟牙膏。同一名经过培训的检查者将对参与者进行随访检查,并在干预后立即以及在4周和8周间隔时确定最敏感牙齿(治疗前SS最高)的牙本质过敏的SS。

讨论

对于老年人专业应用的脱敏剂的护理标准尚无共识。本试验将为临床医生为患有牙本质过敏的老年人制定有效的牙科护理计划提供证据。

试验注册

NCT05392868,于2022年5月22日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/b292f281be9e/dentistry-10-00194-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/cda17e6c5e0c/dentistry-10-00194-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/cf0d8540a29d/dentistry-10-00194-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/b292f281be9e/dentistry-10-00194-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/cda17e6c5e0c/dentistry-10-00194-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/cf0d8540a29d/dentistry-10-00194-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05cf/9600009/b292f281be9e/dentistry-10-00194-g003.jpg

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Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults: Study Protocol for a Randomised Double-Blind Study.38%氟化亚锡银治疗中国老年成年人暴露根面牙本质过敏症的疗效:一项随机双盲研究的研究方案
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