An evaluation of safety, Efficacy and Treatment Adherence of Gandoosha (Oral Oil Retention Procedure) on Orodental Health in apparently healthy adult population- An assessor blind exploratory Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. Salivary Microbiome Profiles (Day 0 and Day 21)
研究概览
简要总结
An assessor-blind randomized controlled trial is proposed in order to evaluate and establish the safety, tolerability, and efficacy of Gandoosha (Oral Oil Retention Procedure*)* on orodental health in the context of healthy oral condition in the apparently healthy adult population.
Apparently, Healthy adult individuals will be randomized into two groups. The treatment group will undergo Gandoosha procedure with Murchita Sesame oil plus routine self-orodental healthcare practices and control group will undergo only routine self-orodental healthcare practices for 21 days.
All the participants will be assessed before, during, and after interventions for changes in oral microbial count, dental plaque index, gingival index, and various symptoms like halitosis, tastelessness in healthy individuals, and also for conditions like mouth ulcers, halitosis, and dental caries.
Along with efficacy, safety, and tolerability and adherence to the Gandoosha procedure will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Apparently Healthy Adults of age group from 18 to 60 years of all genders 2.Apparently Healthy Adults with or without removable or fixed prostheses or fixed and removable orthodontic appliances will be included.
- •3.Poor orodental hygiene with Simplified Oral Hygiene Index (OHI-S)- 3 to 6.
排除标准
- •1.Population with uncontrolled systemic comorbidities like DM, HTN, IHD from available reports & ongoing medication record 2.Population with significant orodental pathology 3.Oral carcinoma in situ.
- •4.Oral premalignant conditions like- Erythroplakia, leukoplakia, OSMF (Screened participants with cancerous, precancerous lesions will be referred to Tata Memorial Hospital for further evaluation and management) 5.Use of antibiotics and anti-inflammatory drugs in previous one month 6.History of mouth rinses, gels or chewing gums use, that contain antimicrobial agents in the preceding one month 7.Chronic users of tobacco products (for more than three years) in its various forms 8.Participants with a history of regular or recent inhalation of corticosteroids 9.Allergy to any ingredient used in the study 10.Oral pathology that is interfering with the conduction of Gandoosha procedure- like OA/RA of TM joint 11.Participants with already a habit of practicing Gandoosha with any liquid 12.Pregnant or lactating females 13.Participants with hampered cough reflex.
结局指标
主要结局
1. Salivary Microbiome Profiles (Day 0 and Day 21)
时间窗: Day 0 and | Day 21
2. Simplified Oral Hygiene Index (OHI-S) (Day 0 and Day 21)
时间窗: Day 0 and | Day 21
次要结局
- 1. Status of orodental health assessed on the basis of WHO Oral Health Assessment form- Adults(2. Change in existing orodental clinical signs and symptoms, if present (E.g.- tastelessness, halitosis, dental pain, sensitive tooth, mouth ulcers, gingival pain, bleeding etc.))
研究者
Dr R Govind Reddy
RRAP CENTRAL AYURVEDA RESEARCH INSTITUTE, Mumbai, CCRAS, MINISTRY OF AYUSH, GOVERNMENT OF INDIA