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临床试验/NCT03222960
NCT03222960Unknown不适用

Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients: Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2017年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
Improving caries risk

研究概览

简要总结

This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients.

详细描述

A total of 40 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of Toothpaste (A) where group A1 patients will use propolis containing toothpaste twice daily while group A2 patients will use fluoride containing toothpaste twice daily as control with 20 patients in each group. Each group will be further divided into three groups according to caries risk assessment times (T) where T0 represents caries risk assessment of patients before application of propolis and fluoride toothpastes and T1 represents caries risk assessment of patients after three months of application of propolis and fluoride toothpastes, T2 represents caries risk assessment of patients after six months of application of propolis and fluoride toothpastes.

Both Propolis containing toothpaste and fluoride containing toothpaste will be placed in concealed tubes. The tubes will completely wrapped by plain white tape to conceal the formulation of toothpaste. Participants are given the tubes of toothpaste and soft brush with a coloured mark at 2 cm length of the bristle surface. The technique can be summarised in four steps:

  1. 2 cm of the toothpaste will be squeezed over the wet toothbrush bristles
  2. The upper and lower teeth will be brushed for 2 min;
  3. After brushing, the remaining toothpaste foam and saliva "slurry" will be swished around the dentition with active movements of the cheeks, lips and tongue, forcing the slurry in between the teeth for about 20 seconds before expectorating the slurry
  4. No post-brushing water rinsing will be carried out All these steps will be presented in a reminder card and all patients will put a tick mark for every step.

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
Single (Participant)

入排标准

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

入选标准

  • Participants should be over 18 years of age.
  • Participants should be high caries risk.
  • Systematically healthy.
  • Not taking any medication interfering with saliva secretion.
  • Participants who signed informed consent.
  • Exclusion criteria:
  • Participants with a compromised medical history.
  • Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
  • Severe or active periodontal disease.
  • History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.

排除标准

  • 未提供

研究组 & 干预措施

Propolis-containing toothpaste

Experimental

Assessment of caries risk for participants using Propolis-containing toothpaste before the treatment , after 3 months and 6 months follow up.

干预措施: propolis-containing toothpaste (Drug)

Fluoride-containing toothpaste

Experimental

Assessment of caries risk for participants using Fluoride-containing toothpaste before the treatment , after 3 months and 6 months follow up.

干预措施: Fluoride-containing toothpaste (Drug)

结局指标

主要结局

Improving caries risk

时间窗: 6 months

caries risk assessment

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

Mahmoud Fawzy Meselhy Maarek

Assistant lecturer

Cairo University

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