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临床试验/NCT03877705
NCT03877705Unknown早期 1 期

Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
98
试验地点
1
主要终点
Salivary bacterial count

研究概览

简要总结

This study will be conducted to evaluate the effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.

详细描述

This study will be conducted to evaluate the value of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline T0, then after 5minutes T1, then at 15 days T3. Salivary pH will be measured by using pH meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin

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 (Investigator, Outcomes Assessor)

盲法说明

The operator will be blinded to material and assessors will be blinded to the material assignment.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range above 65 years old
  • Bedridden patients
  • Males or females
  • Concious patients
  • Co-operative patients approving to participate in the trial.
  • Subjects who signed informed consent

排除标准

  • Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study
  • Subjects who wore removable prosthesis
  • Patients with systemic diseases that have any oral manifestations
  • History of Smoking
  • Allergy to any of chewing gum or tablets ingredients
  • Evidence of tempromandibular joint disorders
  • Presence of intraoral infections
  • Currently using any mouth rinse

研究组 & 干预措施

Dissolving xylitol chewable tablets

Experimental

Listerine ready tabs 3 times/day

干预措施: Listerine ready tabs (Drug)

Xylitol chewing gum

Active Comparator

Trident original 3 times/day

干预措施: Listerine ready tabs (Drug)

结局指标

主要结局

Salivary bacterial count

时间窗: 15 days

Streptococcus mutans count in saliva

次要结局

  • Interdental plaque Bacterial count(15 days)

研究者

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

Manar abd elmageed ahmed

Manar abd El mageed ahmed

Cairo University

研究点 (1)

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