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临床试验/NCT03515902
NCT03515902已完成不适用

The Effects of Mouthguard With Desensitizing Toothpaste in Reducing Dental Hypersensitivity in Swimmers : A Randomized Clinical Trial

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste

研究概览

简要总结

Tooth hypersensitivity due to dental erosion is one of the most common problem related to swimming in improper pH chlorinated pools. Because the teeth are exposed to acidic water for a long time, which cause the loss of dental hard tissue. Tooth hypersensitivity can lead to a negative effect on daily life such as dietary selection, maintaining optimal dental hygiene and beauty aspects. It has been found that using mouthguard while swimming can prevent the teeth directly contact to chlorinated water, so it can protect tooth structure and decrease tooth hypersensitivity. Moreover, using mouthguard with viscous products can seal the gaps between mouthguard and teeth which can help to protect tooth structure and decrease dental hypersensitivity more effectively. At present, there are many desensitizing products such as toothpaste, mouthwash and chewing gum. Desensitizing toothpaste is the most common over-the-counter (OTC) materials in desensitizing. Many research has endorsed the properties of desensitizing toothpaste that can reduce tooth tissue loss and helps to reduce tooth hypersensitivity effectively. So it can be hypothesize that when use the combination of mouthguard with desensitizing toothpaste, it might have synergistic effect on reducing tooth hypersensitivity in swimmers.

详细描述

Tooth erosion is the loss of dental hard tissue due to acidic agents without bacteria involvement.

Mouthguard is a protective appliance use for covering the teeth and gums to prevent the teeth from acidic chlorinated water.

Desensitizing toothpaste is toothpaste containing 8 percent arginine and calcium carbonate that can reduce tooth demineralization and promote remineralization.

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
Single (Investigator)

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 13-25 years (age under 18 years must obtain consent from parents)
  • Swimming at least 5 hours/week
  • Having tooth hypersensitivity from erosion
  • Can read or understand Thai language

排除标准

  • History of allergic to toothpaste
  • Having any tooth which will affect to the tightness of mouthguard
  • Having fixed orthodontic appliance

研究组 & 干预措施

mouthguard

Experimental

Mouthguard arm is application of mouthguard while swimming

干预措施: mouthguard (Device)

mouthguard with desensitizing toothpaste

Experimental

Mouthguard with desensitizing toothpaste arm is application of mouthguard with desensitizing toothpaste containing 8% arginine and calcium carbonate while swimming

干预措施: mouthguard with desensitizing toothpaste (Device)

结局指标

主要结局

Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste

时间窗: baseline,2,4 and 8 weeks

* Tooth hypersensitivity changes will be measured by the mean difference of visual analog scale (VAS) score at baseline,2,4 and 8 weeks by using 2 clinical stimuli including tactile and cold stimulation. Each stimulation will be measured and separately recorded as follow : 1.Tactile stimulation * The score range from 0 (no tooth hypersensitivity) to 100 (worst possibly tooth hypersensitivity) * The mean difference of tooth hypersensitivity from tactile stimulation at any time point will be analyzed. 2. Cold stimulation * The score range from 0 (no tooth hypersensitivity) to 100 (worst possibly tooth hypersensitivity) * The mean difference of tooth hypersensitivity from cold stimulation at any time point will be analyzed.

次要结局

  • The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste(2,4 and 8 weeks)

研究者

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

Kemporn Kitsahawong

Associate Professor

Khon Kaen University

研究点 (2)

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