跳至主要内容
临床试验/NCT07113847
NCT07113847进行中(未招募)2 期

Effectiveness of Resin-Based Desensitizer and Laser, Compared to Fluoride Varnish in Management of Dentine Hypersensitivity in Non-carious Cervical Lesions

British University In Egypt1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年4月1日最近更新:
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
84
试验地点
1
主要终点
visual analogue scale (VAS)

研究概览

简要总结

84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study.

Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients.

详细描述

  1. Participants Randomization and Allocation:

Using computer generated randomization, the participants will be allocated randomly into four equal groups.

The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned. 2. Interventions:

Grouping 84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study.

Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Resin-Based Desensitizer

Active Comparator

干预措施: Resin-Based Desensitizer (Biological)

Laser Desensitizer

Active Comparator

干预措施: Laser Desensitizer (Device)

Combination of Laser + Resin-Based Desensitizer

Active Comparator

干预措施: Resin-Based Desensitizer (Biological)

Combination of Laser + Resin-Based Desensitizer

Active Comparator

干预措施: Laser Desensitizer (Device)

Fluoride-Based Desensitizer

Active Comparator

干预措施: Fluoride-Based Desensitizer (Biological)

结局指标

主要结局

visual analogue scale (VAS)

时间窗: 0,3,6 months

post-operative hypersensitivity assessment with the visual analogue scale from 0-10 with 0 is the minimum sensitivity record and 10 is the maximum sensitivity record

次要结局

未报告次要终点

研究者

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

Amr Shalaby

Demonstrator

British University In Egypt

研究点 (1)

Loading locations...

相似试验