A Single Arm Open Label Interventional Study To Evaluate The Efficacy & Safety Of Gurunanda Signature Whitening Strips Teeth Whitening:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1) To assess improvement in VITA Shade Scale
研究概览
简要总结
30 adults requiring whitening intervention to improve shade Cosmetically will consider for the study.
They will use the GuruNanda’s Signature Whitening Strips once daily for 7 days.
Primary Outcome:
-
To assess improvemnt in VITA SHADE scale over physical visits
-
Air Blast Hypersensitivity using dental air syringe
-
To assess the Enamel by Visual Inspection
-
To assess the Enamel by Tactile Examination
-
Picture of Oral Cavities
Time Points : Baseline, Day 1, Day 3, Day 5 and Day 7
Secondary Outcome:
-
TO observe the safety of Investigation Product throughout the study period
-
Additionally, the oral hard tisses will be observe and abnormal finding questionnaire: burning mouth, altered taste, sore mouth, ulcers, change in gum colors, sensitivity etc
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy adult subjects in the age group of 18-60 years who require oral hygiene support for maintaining or improving teeth shade cosmetically and who agreed to comply with the study procedures.
排除标准
- •Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures; Subjects with chronic or aggressive periodontitis; who underwent recent whitening intervention Tobacco consumers and smokers, betel chewers Subjects who are pregnant or lactating.
- •Subjects with hypersensitivity to any of the test products.
- •Subjects with pre-existing tooth sensitivity Concurrent use of any other treatment for teeth whitening or sensitivity Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment.
结局指标
主要结局
1) To assess improvement in VITA Shade Scale
时间窗: Baseline,30 mins, at the end of Day,1, Day 3, Day 5 and Day 7
over physical visits
时间窗: Baseline,30 mins, at the end of Day,1, Day 3, Day 5 and Day 7
2)Air Blast Hypersensitivity
时间窗: Baseline,30 mins, at the end of Day,1, Day 3, Day 5 and Day 7
3)To assess the Enamel by Visual Inspection 4)) To assess the Enamel by Tactile Examination: 5) Pictures of Oral Cavities
时间窗: Baseline,30 mins, at the end of Day,1, Day 3, Day 5 and Day 7
次要结局
- 1) To observe the safety of the Investigational Product throughout the study period for any abnormal findings on gingival and mucosal tissues, dental hard tissues, including but not limited to the gingiva (free and attached), hard and soft palate, oropharynx/uvula, buccal mucosa, tongue, floor of the mouth, labial mucosa, mucobuccal / mucolabial folds, lips, and perioral area.
研究者
Dr Indumathi BDS MDS PhD
Deepam Hospitals