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临床试验/NCT05392868
NCT05392868招募中2 期

A Clinical Protocol on the Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
166
试验地点
1
主要终点
Change in dentine hypersensitivity

研究概览

简要总结

Background: Dentine hypersensitivity is a common oral complaint from older adults. It induces pain, affects oral hygiene practice, limits food choices and negatively affects the quality of life. Silver diamine fluoride (SDF) is a desensitizing agent but well-designed clinical trials are lacking. The objective of this study is to evaluate the effectiveness of SDF in reducing dentine hypersensitivity in older Chinese adults.

Methods: This is a double-blinded randomised clinical trial recruiting 166 healthy older adults aged 65 or over after having written consent. A trained calibrated examiner will conduct clinical examination and assess dentine hypersensitive using a blast of compressed air delivered from 3-in-1 syringe. Older adults with a tooth with a self-perceived sensitivity score (SS) of 8 or above will be recruited. They will then be block randomised to receive either 38% SDF solution or 5% potassium nitrate every 4 weeks on the exposed root surface of the most hypersensitive tooth. The visible plaque index, bleeding on probing and probing depth (mm) will be recorded on the most hypersensitive tooth. The same examiner will perform clinical examination and assess the dentine hypersensitivity using the same tools and methods at 4-week and 8-week follow-ups. The examiner and older adults will be blinded to treatment allocation. The primary outcome is the percentage of change in SS before and after intervention at 8 weeks. The secondary outcome will be the percentage of change in VPI before and after intervention at 8 weeks.

Clinical significance: It will provide evidence to manage dentine hypersensitivity in older adults in clinical care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • generally healthy;
  • no known or suspected allergy to the study ingredients or materials
  • have all active dental diseases under control but reported hypersensitivity

排除标准

  • using any desensitizing agent within one month
  • have major systemic diseases such as cancer
  • receive medications that may affect pain perception within one month
  • have dentine hypersensitivity due to other dental conditions such as caries
  • are not able to give written consent

结局指标

主要结局

Change in dentine hypersensitivity

时间窗: at 8-week follow-up

the percentage of change in self-perceived sensitivity score (SS)

次要结局

  • Change in oral hygiene status(at 8-week follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun Hung Chu

Clinical Professor

The University of Hong Kong

研究点 (1)

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