A comparative clinical study to evaluate the efficacy of Ayurvedic Dentifrices in providing dental protection
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. Improvement in teeth health basis dental examination (Teeth surface, Plaque and Caries) with regular use of study product in comparison to the baseline and with White toothpaste
研究概览
简要总结
This will a comparative study to evaluate the effect of Ayurvedic Dentifrices in providing dental protection in comparison to the baseline and/or white toothpaste. There will be four arms in the study. A total of 140 subjects (35 in each group to get minimum 30 completers ) will be enrolled. Study intervention period will be of one month. Results will be analyzed using suitable statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects in age group 18 – 55 years (both the ages inclusive).
- •2.Having at least 16 natural, permanent teeth.
- •3.Subjects with poor dental hygiene (self-reported and clinically diagnosed) 4.Subjects who have plaque and dental caries.
- •(Caries score up to 2 using International Caries Detection and Assessment System (ICDAS).
- •5.Subjects with extrinsic dental stains (Score up to 2 using Lobene Stain Index) 6.Subjects willing to give their oral swab samples for analysis.
- •7.Subjects willing to come for follow up visits at the specified time.
- •8.Subjects ready to follow study related procedures during the study period.
排除标准
- •1.A known history or present condition of hypersensitivity to any toothpaste and tooth powder 2.Subjects taking any supplementation known to support teeth health which may interfere study results.
- •3.The use of antibiotic, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
- •4.Any history of periodontal therapy by surgical interventions.
- •5.Subjects with active periodontal conditions.
- •6.Subjects who have used any medicated/fluoridated toothpastes.
- •8.Any removable device such as a removable partial denture or orthodontic retainer.
- •9.The presence of any fixed appliance, large or defective restorations, cracked enamel, 10.Subjects who have a history of smoking or use smokeless tobacco products/betel chewing 11.Subjects who are pregnant or lactating 12.Subjects having severe level of calculus and/ tartar.
- •13.Any underlying systemic illnesses, medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, a positive HIV status, hepatitis etc.
结局指标
主要结局
1. Improvement in teeth health basis dental examination (Teeth surface, Plaque and Caries) with regular use of study product in comparison to the baseline and with White toothpaste
时间窗: Day 1 and Day 30
2. Improvement in gum health (colour, consistency, gum bleeding) as per the dental examination (Gingiva) with regular use of study product in comparison to the baseline and with White toothpaste
时间窗: Day 1 and Day 30
次要结局
- •Reduction in teeth stains(•Reduction in malodour causing bacteria)