Using a Mouthwash Containing Propolis, Clove Oil and Chlorhexidine to Improve the Caries Risk of High Risk Patients: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Caries Risk Assessment
研究概览
简要总结
This study is conducted to determine if using a mouthwash containing propolis, clove oil and chlorhexidine will improve the caries risk of high risk patients in comparison to using a mouthwash containing chlorhexidine only.
详细描述
A total of 64 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of mouthwash (A) where group A1 patients will use chlorhexidine mouthwash as control group while group A2 patients will use chlorhexidine with propolis and clove oil mouthwash as intervention group with 32 patients in each group. Each group will be further divided into two groups according to times of application (T) where T1 represents patients using the mouthwash once daily for one week every month for 6 months and T2 where patients will use the mouthwash twice daily for one week every month for 6 months with 16 patients in each subgroup.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation of mouthwash and times of applications to groups will be done through sealed opaque sequentially numbered containers to ensure absolute concealment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should be over 18 years of age.
- •Patients should be with high caries risk assessment.
排除标准
- •Patients with a compromised medical history.
- •Severe or active periodontal disease.
- •Patients with a diseased salivary gland
- •History of allergies or other adverse reactions to chlorhexidine, propolis, bee stings, or clove
- •Patients on any antibiotics during the past month
结局指标
主要结局
Caries Risk Assessment
时间窗: 6 month
Patient caries risk assessment will be measured using the cariogram model
次要结局
未报告次要终点
研究者
Moataz Gamal Ali Abdul-Maksoud Konsouh
Master Candidate at Conservative Department
Cairo University