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临床试验/NCT03061422
NCT03061422Unknown不适用

Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH in High Caries Risk Patients (A Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 36 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
36
试验地点
1
主要终点
Salivary pH change

研究概览

简要总结

36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are exposed to paraffin pellet chewing. The pH of saliva will be evaluated according to time in relation to the gum chewing (T) where (T0) represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am).

Direct benefit of the research to the human volunteer:

It is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost.

Scientific value and social benefits:

This study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. Also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods.

Expected risk to the human subjects:

Allergic reactions due to any of the components of the materials used which is rare to occur.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Patients eligible for the trial must comply with all of the following at randomization.
  • Age range from 20-50 years
  • High caries risk patients defined according to American Dental Association (ADA)
  • Acidic baseline saliva pH
  • Systematically healthy
  • Not taking any medication interfering with saliva secretion
  • Subjects who signed informed consent

排除标准

  • (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients

结局指标

主要结局

Salivary pH change

时间窗: an average of 1 year

will be done by digital pH meter

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

Howaida Fakhry Fouad

Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university 2012

Cairo University

研究点 (1)

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