此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine Hypersensitivity

2026年6月10日 更新者:Yaşar Tolga KAYIM、Ondokuz Mayıs University

Comparison of Nd:YAG Laser, Diode Laser, Herbal Propolis-Based Dentin Barrier Agent, and Sham Application in the Treatment of Dentine Hypersensitivity: A Randomized Controlled Clinical Trial

Dentine hypersensitivity is a common clinical problem. Although Nd:YAG lasers, diode lasers, and topical desensitizing agents are widely utilized, long-term comparative evidence regarding their clinical efficacy remains limited. This prospective, randomized, parallel-arm, evaluator-blind, sham-controlled clinical trial evaluated and compared the 12-month clinical performance of an Nd:YAG laser, a diode laser, a herbal propolis-based dentin barrier agent, and a sham application.

研究概览

详细说明

This study was conducted as a prospective, randomized, parallel-arm, evaluator-blinded, sham-controlled clinical trial to evaluate and compare the clinical efficacy of four different treatment modalities for dentine hypersensitivity over a 6-month follow-up period.

A total of 140 patients who met the eligibility criteria were enrolled and randomly allocated into four equal groups (n=35 per group) using a block randomization method with a 1:1:1:1 allocation ratio. The intervention groups were assigned as follows:

Group 1 received Nd:YAG laser application.

Group 2 received Diode laser application.

Group 3 received a topical application of a herbal propolis-based dentin barrier agent.

Group 4 received a sham (placebo) application to simulate the treatment experience without delivering any active laser or therapeutic agent benefits.

Clinical evaluations were performed at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months. The primary outcome was the change in pain intensity measured by the Visual Analog Scale (VAS) following a controlled air blast stimulus from baseline to 6 months. Secondary outcomes included changes in the Schiff Cold Air Sensitivity Scale, tactile sensitivity scores, patient satisfaction levels, the documentation of any adverse events, and the need for additional treatment during the 6-month period. To ensure objectivity, all clinical assessments and statistical analyses were performed by researchers who were fully blinded to the treatment allocations.

研究类型

介入性

注册 (实际的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Samsun
      • Samsun、Samsun、土耳其(türkiye)、55270
        • Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged between 18 and 65 years.
  • Presence of at least two hypersensitive teeth.
  • Visual Analog Scale (VAS) score of 4 or higher (VAS >= 4) following stimulus.
  • Schiff Cold Air Sensitivity Scale score of 2 or higher (Schiff >= 2).
  • Presence of vital teeth in the target area.
  • Patient is willing and able to provide written informed consent prior to study initiation.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Presence of active periodontal disease in the target area.
  • Teeth with dental caries, deep restorations, or cracked tooth syndrome.
  • Endodontically treated teeth.
  • History of allergy or hypersensitivity related to the materials, products, or chemical agents used in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group 1: Nd:YAG Laser
Participants assigned to this group received Nd:YAG laser application targeted at the hypersensitive teeth to achieve desensitization. The procedure was completed during the treatment session according to the clinical protocol.
Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
实验性的:Group 2: Diode Laser
Participants assigned to this group received Diode laser application on the affected dentine areas for hypersensitivity treatment. The application was performed in accordance with the specified parameters.
Diode laser application performed for the treatment of dentine hypersensitivity.
实验性的:Group 3: Dentin Barrier Agent
Participants assigned to this group received a topical application of a herbal propolis-based dentin barrier agent onto the hypersensitive tooth surfaces. The agent was applied to seal the dentinal tubules and reduce sensitivity.
Topical application of a herbal propolis-based dentin barrier agent.
假比较器:Group 4: Sham Application
Participants assigned to this group received a sham (placebo) procedure designed to completely simulate the laser or topical application experience without delivering any active laser energy or therapeutic desensitizing agent. This group served as the control to account for the placebo effect.
Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Visual Analog Scale (VAS) Score after Air Stimulus
大体时间:Baseline and 6 months
Pain intensity evaluated using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (extreme/worst pain). The primary outcome is defined as the change in pain intensity in response to a controlled air blast stimulus from baseline to 6 months.
Baseline and 6 months

次要结果测量

结果测量
措施说明
大体时间
Schiff Cold Air Sensitivity Scale Score
大体时间:Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Dentine sensitivity assessed using the Schiff Cold Air Sensitivity Scale, where scores range from 0 (patient does not respond to air stimulus) to 3 (patient responds to air stimulus, experiences pain, and requests discontinuation of stimulus).
Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Tactile Sensitivity Score
大体时间:Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Tactile sensitivity evaluated using a standard dental explorer probe passed across the affected dentine surface to record the presence or absence of discomfort or pain.
Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月15日

初级完成 (实际的)

2026年6月10日

研究完成 (实际的)

2026年6月10日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared publicly to ensure patient confidentiality and compliance with the ethical committee approval, which did not include a provision for public data repository sharing.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅