A clinical study to evaluate the efficacy of banadi oil to maintain the oral hygiene in pediatric age group
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in oral hygiene status bacterial count and oral hygiene index from baseline to post treatment after intervention period
研究概览
简要总结
Poor oral hygiene can significantly affect general health, and several oral diseases are associated with chronic systemic conditions. In modern lifestyles, excessive consumption of fast food, carbonated beverages, spicy foods, and the use of substances such as ice cream, chocolate categorized in Ayurveda as apathyakar (unwholesome)—disturb the normal flora of mouth and gut contribute to the development of oral diseases. These conditions often manifest as redness, ulcerations in the oral cavity, burning sensations, and pain.
Any disruption in the natural balance of oral flora may indicate underlying systemic or local diseases. The ancient Ayurvedic texts highlight procedures such as Dantadhavan (brushing of teeth), Jivha Nirlekhan (tongue scraping), and Gandush (oil or decoction holding in the mouth) as essential components of Dinacharya (daily regimen) to maintain oral hygiene.
This clinical study aims to evaluate the efficacy of Banadi Taila Pratisaran (local oil application) in maintaining oral hygiene among children aged 2 to 5 years. Poor oral hygiene in early childhood can lead to plaque formation, halitosis, and systemic infections. Banadi Taila, a classical Ayurvedic formulation described in Ashtanga Hridaya (Uttara Sthana 22/88–89), contains herbs such as Barleria strigosa, Khadira, Jambu, Mulethi, Anantmool, Irimed, Amra, Neelkamal, and Til taila, which are known for their antimicrobial and Kapha-Pitta shamaka properties.
The study follows a non-randomized, open-label, single-arm, prospective interventional design with 50 pediatric subjects. Each participant will receive Banadi Taila Pratisaran twice daily for 14 days. Assessment will include both subjective parameters (appetite and halitosis) and objective parameters (oral flora bacteriological count and Oral Hygiene Index–Simplified).
Statistical analysis will be done using the Wilcoxon test for subjective and paired t-test for objective parameters. The expected outcome is a significant reduction in bacterial count and plaque index, validating Banadi Taila as a safe, effective, and traditional Ayurvedic method for maintaining oral hygiene and preventing oral diseases in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 5.00 Year(s)(—)
- 性别
- All
入选标准
- •children with complaints of halitosis(bad breath) and plaque willing and able to participate for the study duration parenta guardian informed and written consent obtained willing to follow study instruction.
排除标准
- •children below 2 year and above 5 years children with underlying and oral disease systemic diseases children with antibiotic use history in the last 15 days.
结局指标
主要结局
change in oral hygiene status bacterial count and oral hygiene index from baseline to post treatment after intervention period
时间窗: intervention given for 14 days post treatment follow up on 15th day
次要结局
- To evaluate the in-vitro antimicrobial effect of banadi taila.(bacterial count and oral hygiene index from baseline to post treatment after intervention period)
研究者
Dr Dipesh Raj
shri narayan prasad awasthi government ayurved college raipur C.G.
