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临床试验/NCT03732040
NCT03732040Unknown不适用

Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
82
试验地点
1
主要终点
Incidence of new caries lesions

研究概览

简要总结

Objectives:

Aim of the study The objective is to conduct an RCT to evaluate the effectiveness of miswak in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.

-Research hypothesis (alternative hypothesis): This study will be designed to test the alternative hypothesis that using miswak in addition to standard preventive measures will show significant difference over using standard preventive measures alone in preventing incidence of new carious lesions in high caries risk patients.

详细描述

  • General procedures The study will be announced at the Faculty of Oral and Dental Medicine, 6 October University campus to encourage interested students to participate in the study.

Interested participants will be screened at Conservative Department clinic for eligibility by (M.M). Eligible participants will be assessed using caries risk assessment tool by (R.R.).

Eligible participants will be randomly divided into three groups 1st group will follow only standard preventive measures(tooth brushing and tooth paste plus interdental cleaning and mouth rinse using CHX and Fluoride) , 2nd group will use miswak for oral hygiene measures and 3rd group will use of miswak plus tooth brushing and tooth paste.

Before starting the study the eligible participants will undergo supragingival, subgingival scaling and prophylaxis polishing, then any carious cavity, or defective restoration will be treated and filled with resin composite restoration.

New set of manual brushes and dental floss will be given to the participants, after they are properly trained for the correct brushing and flossing technique. The participants will be asked to brush their teeth twice a day with fluoride tooth paste and to clean their teeth interdentally with dental floss once a day every day till the end of the study(Group 1 and 3 only) 11b- Preparation of miswak

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 (Outcomes Assessor)

入排标准

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

入选标准

  • • patients with High caries risk
  • 18-25 years
  • Males or females
  • Medically free patients
  • Patients approving to participate in the study

排除标准

  • Patients were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
  • Patients had history of professional cleaning in the last 15 days
  • Patients with exposed pulp
  • Evidence of parafunctional habits
  • Patients with developmental dental anomalies
  • Patients undergoing or will start orthodontic treatment
  • Patients with removable prosthesis
  • Periapical Abscess or Fistula

结局指标

主要结局

Incidence of new caries lesions

时间窗: 12 months

visual tactil inspection

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

Rania Rashad Omar

Miswak versus standard measures to prevent the incidence of caries young Egyptian adults: A Randomized Controlled Clinical Trial

Cairo University

研究点 (1)

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