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临床试验/NCT06276777
NCT06276777尚未招募不适用

The Effect of Using Desensitizers Containing S-PRG Versus Sodium Fluoride With Functionalized Tri-Calcium Phosphate In Treatment Of Dentin Hypersensitivity In Adult Patients Over 6 Months: A Randomized Clinical Trial

Eman Omar Elfarouk2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
Dentin hypersensitivity reduction

研究概览

简要总结

The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.

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)

盲法说明

Participants and both assessors will be blind to the type of material used.

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

  • Good oral hygiene.
  • Cooperative patients who show interest to participate in the study and welling to sign the informed consent.
  • Healthy patients with no history of previous systematic diseases that can affect their oral health.
  • Normal and healthy gingival tissue.
  • Teeth that have no cavitation or restorations.
  • Patients with at least 20 natural permanent teeth and at least two teeth with a VAS score from 4 to
  • Anterior teeth.

排除标准

  • Allergic to the ingredients used in the study.
  • Gastrointestinal disorders (They have repeated vomiting attacks).
  • Medically compromised (They cannot tolerate the procedures).
  • Taking desensitizing treatment in the last 6 months (It affects the outcome).
  • Taking anti-inflammatory drugs (It affects the hypersensitivity perception).
  • Pregnant females (They complain from nausea and repeated vomiting attacks)
  • Smokers (Smoking will affect the oral hygiene and periodontal health).

研究组 & 干预措施

Varnish contains S-PRG (PRG Barrier Coat from Shofu)

Experimental

Treatment of dentin hypersensitivity by application of tooth varnish containing S-PRG.

干预措施: Tooth varnish (PRG Barrier Coat from Shofu) (Procedure)

Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M)

Active Comparator

Treatment of dentin hypersensitivity by application of tooth varnish containing sodium fluoride with functionalized tri-calcium phosphate.

干预措施: Tooth varnish (Clinpro white varnish 3M) (Procedure)

结局指标

主要结局

Dentin hypersensitivity reduction

时间窗: assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.

The participants will point out the degree of sensitivity on the VAS scale (0-10) chart.

次要结局

未报告次要终点

研究者

发起方
Eman Omar Elfarouk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eman Omar Elfarouk

masters degree student

Cairo University

研究点 (2)

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