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临床试验/NCT03061383
NCT03061383Unknown不适用

Reduction of Dentine Hypersensitivity Using 8% Arginine Based Toothpaste and 8% Strontium Acetate Based Toothpaste: Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年3月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
51
试验地点
1
主要终点
reduction of dentin hypersensitivity

研究概览

简要总结

This is a randomized, triple-blind, placebo-controlled study. 51 subjects with a confirmed diagnosis of dentin hypersensitivity were randomized to one of three treatments: Arginine based toothpaste, strontium acetate based toothpaste , or placebo. Treatment will be done at baseline then patients will use the toothpaste at home twice per day by using soft bristled tooth brush and the given dentifrice using modified stillmans method as explained by examiner. Standard test stimuli is calibrated short blast of air syringe, will be applied to sensitive dentin surfaces. Subjects recorded the intensity of sensitivity in response to stimulus on a visual analog scale at baseline, and after 1 week, 2 weeks and 3 months.

详细描述

  • Study setting This study will be carried out on adult patients attending to the operative clinic in The Faculty of Oral and Dental Medicine, Cairo University, Egypt. The procedures will be carried out by postgraduate student esraa abdel ghaffar ahmed ali [B.D.S. 2012 from Misr International University] without an assistant.

  • Eligibility criteria

  • Inclusion criteria Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.

Subjects aged between 18-35 years At least three sensitive teeth (buccal /facial) aspect with recession , abrasion, erosion with a score of >3 on verbal rating scale, ranging from 0-3= no pain/mild pain, 4-6= moderate pain, and 7- 10= severe pain. Subjects were required to be available for the duration of the study, and to sign an informed consent form

-Exclusion criteria Subjects with a history of allergy to any of the drugs or chemicals used in the study.

Any removable appliance (RPD or orthodontic retainer). Ongoing orthodontic treatment with fixed appliances.

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, Care Provider, Outcomes Assessor)

盲法说明

It will be a triple blinded study so that the participant, the researcher and the data analysis will be blinded.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
  • Subjects aged between 18-35 years
  • At least three sensitive teeth (buccal /facial) aspect with recession , abrasion, erosion with a score of >3 on verbal rating scale, ranging from 0-3= no pain/mild pain, 4-6= moderate pain, and 7- 10= severe pain.
  • Subjects were required to be available for the duration of the study, and to sign an informed consent form

排除标准

  • Subjects with a history of allergy to any of the drugs or chemicals used in the study.
  • Any removable appliance (RPD or orthodontic retainer). Ongoing orthodontic treatment with fixed appliances.
  • Presence of any large or defective restorations, cracked enamel or caries on the hypersensitive tooth.
  • Pregnancy and lactating mothers.
  • Dental pathology causing pain similar to dentin hypersensitivity.
  • Patients with any systemic problem or mental or physical disability

结局指标

主要结局

reduction of dentin hypersensitivity

时间窗: 3 months

Subjects recorded the intensity of sensitivity in response to stimulus on a visual analog scale

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

Esraa Abdel Ghaffar Ahmed Ali

Reduction of dentine hypersensitivity using 8% Arginine based toothpaste and 8% Strontium acetate based toothpaste: Randomized Controlled clinical trial

Cairo University

研究点 (1)

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