A Comparative Study of Herbal Mouthwash as Dispersible Tablets: Seabuckthorn and Jamun Seed Extracts vs Chlorhexidine for Assessment of Plaque Index of Children in age group of 7-14 years- A Double-Blinded Randomized Clinical Trail.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period.
研究概览
简要总结
This randomized, double-blinded clinical trial aims to compare the efficacy of herbal mouthwash formulated as dispersible tablets containing Seabuckthorn and Jamun seed extracts with that of standard Chlorhexidine mouthwash tablets. The target population includes children aged 7 to 14 years. The primary objective is to assess and compare the reduction in plaque index among the groups. Secondary objectives include evaluating improvements in gingival health, patient acceptability of the herbal formulation, and recording any adverse effects. By exploring natural alternatives to Chlorhexidine, the study seeks to provide a safer, effective, and child-friendly option for maintaining oral hygiene and controlling dental plaque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 7-14 years Participants in good general health without systemic diseases or conditions affecting oral health.
- •Children who are able to comply with oral hygiene instructions and follow the study protocol.
- •Parents/caregivers acceptance and cooperation.
排除标准
- •Presence of any oral pathology, such as gingival overgrowth or abscesses requiring urgent treatment.
- •Children with orthodontic appliances (e.g., braces or space maintainers) that could interfere with plaque assessment.
- •Systemic health conditions or medications that could influence oral hygiene or microbial flora (e.g., diabetes, immunosuppression).
结局指标
主要结局
The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period.
时间窗: The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period.
次要结局
- Assessment of Gingival Health:(Monitoring changes in gingival index or signs of gingival inflammation to assess any additional periodontal benefit.)