Antibacterial, Antiplaque and Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Gingival index (GI)
研究概览
简要总结
Moringa oleifera (MO) is an extraordinary nutritious vegetable tree with high medicinal value for its antibacterial properties. Formulation of various natural dental remedies from this plant and their testing for their effectiveness might yield promising antibacterial, antiplaque and anticariogenic agents with minimal side effects.
Aim of the study:
Part I: The aim of this in-vitro part of the study is to formulate a nontoxic mouthwash from MO leaves extract, having antimicrobial activity, to be used in part II of the study. Furthermore, stability and efficacy of the developed mouth wash will be evaluated.
Part II: The aim of this randomized controlled trial is to evaluate the antibacterial, antiplaque and anticariogenic effect of MO mouthwash compared to chlorhexidine mouthwash.
详细描述
Statement of the problem: Oral diseases remain a major health problem all over the world. Periodontal diseases and dental caries are the most common non-communicable oral diseases in mankind and the leading cause of tooth loss. Both diseases can lead to nutritional compromise and negative impact on self-esteem and quality of life. As the International situation is now changing towards the use of non- toxic and environmentally friendly products, development of modern drugs from traditional medicinal plants should be emphasized for the control of various human diseases. Moringa oleifera (MO) is an extraordinary nutritious vegetable tree with high medicinal value for its antibacterial properties. Formulation of various natural dental remedies from this plant and their testing for their effectiveness might yield promising antibacterial, antiplaque and anticariogenic agents with minimal side effects.
Aim of the study:
Part I: The aim of this in-vitro part of the study is to formulate a nontoxic mouthwash from MO leaves extract, having antimicrobial activity, to be used in part II of the study. Furthermore, stability and efficacy of the developed mouth wash will be evaluated.
Part II: The aim of this randomized controlled trial is to evaluate the antibacterial, antiplaque and anticariogenic effect of MO mouthwash compared to chlorhexidine mouthwash.
Materials and Methods:
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 (Participant, Care Provider)
盲法说明
Masking of all caregivers, examiners (I) and (II), as well as patients are planned. No one other than HSE at the NRC will know which mouthwash is in each bottle. HSE will not be involved in patient recruitment, follow-up or assessment
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically free as reported by the patients
- •Minimum of 20 teeth present in the dentition (excluding wisdom teeth);
- •Clinically healthy gingiva (on intact periodontium)
- •Dental biofilm-induced gingivitis (plaque induced gingivitis) according to the criteria set by the American Academy of Periodontology for classification of periodontal diseases and conditions in 2017
- •Moderate to high caries risk patients
排除标准
- •Patients with periodontitis or requiring other immediate dental treatments (within the current 6 months)
- •Subjects on antibiotics within last 6 months
- •Periodontal therapy for the past 6 months
- •Pregnant women and lactating mothers
- •Medically compromised patients
- •Subjects with tobacco consumption in any form
- •Subjects wearing partial dentures or having clinically unacceptable restorations or bridges
- •Subjects wearing orthodontic appliances
- •History of allergy to chemical or any herbal products
研究组 & 干预措施
Moringa Oleifera mouth wash
According to part I of the study, we will select the most effective (Non-toxic, anti-bacterial effect) Moringa extract to prepare the mouth wash.
干预措施: Moringa Oleifera (Drug)
Base formula of mouth wash
Base formula of mouthwash
干预措施: Base formula (Drug)
Chlorhexidine
Commercial 0.12% chlorhexidine digluconate mouthwash
干预措施: Chlorhexidine mouthwash (Drug)
结局指标
主要结局
Gingival index (GI)
时间窗: 21 days
as assessed by Lӧe and Silness: Score from 0 to 3, Zero is normal subject
White Spot Lesions
时间窗: 21 days
Assessed by ICDAS II: Scores from 0 to 9: Zero is unrestored or unsealed tooth surface
次要结局
未报告次要终点