Grape Seeds Versus Standard Measures for Prevention of Caries Incidence in Young Egyptian Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 主要终点
- caries incidence
研究概览
简要总结
The objective is to conduct an randomized controlled clinical trial to evaluate the effectiveness of grape seeds extract mouth wash in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
This study will be designed to test the alternative hypothesis that using grape seed extract mouth wash 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
Research Question:
In high caries risk patients, will the incorporation of grape seeds extract after using standard oral hygiene measures be beneficial in reducing caries risk and preventing the incidence of new carious lesions?
Intervention:
The study will be announced at the Faculty of Oral and Dental Medicine, Future University campus to encourage interested students to participate in the study.
Interested participants will be screened at Conservative Department clinic for eligibility. Eligible participants will be assessed using caries risk assessment tool (American Dental Association caries risk assessment form).
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
- 是
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
研究组 & 干预措施
standard preventive measures
the participants will only follow standard preventive measure twice a day brushing with fluoride toothpaste and flossing once a day
干预措施: standard preventive measures (Drug)
antimicrobial and fluoride mouth wash
participants will use mouth wash contains both chlorhexidine and fluoride in addition to standard preventive measures
干预措施: antimicrobial and fluoride mouth wash (Drug)
grape seeds extract mouth wash
the intervention is grape seeds extract mouth wash
干预措施: Grape Seed Extract mouth wash (Drug)
结局指标
主要结局
caries incidence
时间窗: 12 months
visual inspection of new carious lesions
次要结局
未报告次要终点
研究者
Omar Nader
Principal investigator
Cairo University