CTRI/2025/07/090563尚未招募Phase 3 4
Effectiveness of Dant Kanti Gandush Oil Pulling in Improving Oral Hygiene:Prospective,Open-Label,Single-Arm Observational Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Reduction in oral microflora: Total bacterial count and differential bacterial count
研究概览
简要总结
| This single arm, open label, observational, prospective study will evaluate the effect of Dant Kanti Gandush Oil Pulling in oral health. Subjects will be screened based on Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. The eligible subjects will be assigned to use Dant Kanti Gandush Oil Pulling for the next 14 days from the day of enrolment and Gingival score, Plaque scores, organoleptic score, microbial assessment will be evaluated to check the efficacy. Oral Health 15 questionnaire will be used to check oral health. |
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with mild caries risk DMFT score 1 to 2 ( Decayed missing due to caries and Filled Teeth) Subjects with no history of antibiotic administration for the last 2 weeks Subjects with no antimicrobial mouth rinse for the last 12 hours Subjects with no systemic diseases Subjects willing to give their swab samples for analysis Able to provide written informed consent Able and willing to comply with the protocol including availability for all scheduled study visits.
排除标准
- •Patient allergic to any of the ingredients of medicated oil (test product).
- •Any history of periodontal therapy by surgical interventions Subjects with the history of antibiotic use in the past 1 month Tooth with developmental anomalies and fluorosis Pregnant or breastfeeding women.
结局指标
主要结局
Reduction in oral microflora: Total bacterial count and differential bacterial count
时间窗: Baseline (Day 01), Day 07 & Day 14
次要结局
- Reduction in gingival index and plaque index(Baseline (Day 01), Day 07 & Day 14)
- Reduction in Organoleptic scale(Baseline (Day 01), Day 07 & Day 14)
- Improvement in quality of life by using EORTC QOL-OH15(Baseline (Day 01), Day 07 & Day 14)
研究者
Dr Kuldeep Singh
Patanjali Ayurveda Hospital
研究点 (3)
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