Antibacterial Potential of Ethanolic extract of Spilanthes acmella Mouthrinse Against Salivary Streptococcus mutans in Young Adults of Pondicherry- A Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- oBaseline (Day 0)
研究概览
简要总结
Dental caries is a multifactorial infectious disease and ubiquitous in all population throughout the world. The most alarming is a greatest concern from public health point of view. Oral cavity contains wider variety of bacteria, streptococcus mutans and lactobacilli , in that streptococcus mutans are the responsible for the cause of initiation of dental caries. Reduction of streptococcus mutans load in the oral cavity by using antibacterial agent. Herbal is the safe and effective for clinical implication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects with atleast one active caries lesion.
- •The subjects with gingival and or/ periodontal disease
- •The subjects who brush only once daily.
排除标准
- •Patients who received antibiotic therapy within past 3 weeks.
- •The subjects who had preventive dental procedures at last 48 hours.
- •The subjects with limited manual dexterity and systemic illness.
- •Patients giving known history of allergy to any of the constituents of mouth rinses.
结局指标
主要结局
oBaseline (Day 0)
时间窗: Reduction in Salivary Streptococcus mutans Colony Count | •Measured using colony-forming units per milliliter (CFU/mL) in saliva samples. | •Saliva samples collected at: | oBaseline (Day 0) | oAfter 30 days of intervention (Final) | •The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
oAfter 30 days of intervention (Final)
时间窗: Reduction in Salivary Streptococcus mutans Colony Count | •Measured using colony-forming units per milliliter (CFU/mL) in saliva samples. | •Saliva samples collected at: | oBaseline (Day 0) | oAfter 30 days of intervention (Final) | •The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
•The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
时间窗: Reduction in Salivary Streptococcus mutans Colony Count | •Measured using colony-forming units per milliliter (CFU/mL) in saliva samples. | •Saliva samples collected at: | oBaseline (Day 0) | oAfter 30 days of intervention (Final) | •The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
•Saliva samples collected at:
时间窗: Reduction in Salivary Streptococcus mutans Colony Count | •Measured using colony-forming units per milliliter (CFU/mL) in saliva samples. | •Saliva samples collected at: | oBaseline (Day 0) | oAfter 30 days of intervention (Final) | •The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
Reduction in Salivary Streptococcus mutans Colony Count
时间窗: Reduction in Salivary Streptococcus mutans Colony Count | •Measured using colony-forming units per milliliter (CFU/mL) in saliva samples. | •Saliva samples collected at: | oBaseline (Day 0) | oAfter 30 days of intervention (Final) | •The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
•Measured using colony-forming units per milliliter (CFU/mL) in saliva samples.
时间窗: Reduction in Salivary Streptococcus mutans Colony Count | •Measured using colony-forming units per milliliter (CFU/mL) in saliva samples. | •Saliva samples collected at: | oBaseline (Day 0) | oAfter 30 days of intervention (Final) | •The primary outcome evaluates the effectiveness of Ethanolic extract of Spilanthes acmella herbal mouthrinse in reducing bacterial load compared to control groups (Chlorhexidine).
次要结局
- Validated feedback questionnaire at the end of the intervention.(Evaluates participants’ perception of taste, aftertaste, & ease of use.)