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临床试验/NCT03818945
NCT03818945Unknown4 期

Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail

Cairo University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
104
试验地点
1
主要终点
relieving of hypersensitivity

研究概览

简要总结

to solve the problem of hypersensitivity, I will use two different materials ( Giomer versus Sodium Fluoride) and compare between their effects in reliving the symptoms

详细描述

The dentin hypersensitivity is characterized by short, sharp pain which can be detected by several methods. The problem is very annoying for the patients and making them seek for effective rapid treatment.

It can affect several teeth in one area of the mouth or only one specific tooth. Careful diagnosis of such condition necessitates precise differentiation of its signs and symptoms from the other causes of tooth sensitivity which may be resulted from dental caries, micro leakage, cracked tooth or fractured restoration. There are two well-known ways to reduce the discomfort of the hypersensitivity either by blocking the exposed dentinal tubules by occluding materials or use some depolarizing agents that reducing the excitability of the intra dental nerves.Most of the desensitizing agents reduces the dentin hypersensitivity by its own way and each one has different long lasting effect. But there are some drawbacks that appeared with their use. Fluoride based agents were appeared in 90's but it was clarified that their high concentration irritated the odontoblasts. Furthermore, the oxalates and potassium nitrate were introduced to treat the hypersensitivity effectively but their effects did not persist for a long period of time.

Sodium fluoride varnish is one from the most commonly used desensitizing agent and its efficacy was approved in many studies. The Giomer varnish containing surface pre-reactive glass particles (S-PRG) is a light-cured protective varnish and it was introduced to promote prolonged protection for the hypersensitive dentin.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 18 to 40 years.
  • No gender restriction.
  • Patients should have pain score in the visual analog scale two or more.
  • Patients must have at least one sensitive tooth in one of four quadrants.

排除标准

  • Patients with active carious lesions.
  • Needing restorative treatment.
  • Receiving periodontal treatment.
  • Taking desensitizing treatment in the last 6 months.
  • Taking anti-inflammatory drugs.
  • Pregnant patients.

研究组 & 干预措施

Sodium Fluoride Varnish

Other

干预措施: Sodium fluoride varnish (Drug)

PRG barrier Giomer

Active Comparator

干预措施: shofu PRG barrier coat (Drug)

结局指标

主要结局

relieving of hypersensitivity

时间窗: one month

The sensitive teeth will be assessed by two stimuli: tactile and thermal stimuli than scored according to the visual analog scale from zero to ten.

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

Nourane Yasser Ali

Principal investigator in Cairo university

Cairo University

研究点 (1)

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