Assessing the efficacy & safety of GuruNanda Signature Whitening Strips versus Lumineux Whitening Strips in teeth whitening: A double blind, randomized, comparative clinical study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) To assess improvement in VITA Shade Scale over physical visits
研究概览
简要总结
60 adults requiring whitening intervention to improve teeth shade cosmetically, divided into 2 arms of 30 in each arm.
Group 1 ( n=30) - Subjects will use - GuruNanda’s Signature Whitening Strips once daily for 7 days.
Group 2 (n=30) - Subjects will use- Lumineux Whitening Strips, once daily for 7 days.
Primary Outcome :
-
To assess improvement 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
-
Pictures of Oral Cavities
Timepoints : Baseline,Day 1, Day 3, Day 5 and Day 7
Secondary Outcome
- To observe the safety of Investigational Product throughout the study Period
2) Additionally, the oral hard tissues 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
- Randomized
- 盲法
- Participant and Investigator 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
- •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 over physical visits
时间窗: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study
2)Air Blast Hypersensitivity using dental air syringe-Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, and distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale. This analog scale scores for the tooth are 0, 1, 2 or 3:
时间窗: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study
3) To assess the Enamel by Visual Inspection: Dentists visually inspect teeth for signs of enamel erosion, discoloration, and surface roughness. Healthy enamel should appear smooth, translucent, and glossy
时间窗: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study
4) To assess the Enamel by Tactile Examination: Using dental probes, the dentist can feel the texture of the enamel Mohs Hardness Scale for Enamel. Rough or pitted surfaces may indicate enamel wear or demineralization
时间窗: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study
5) Pictures of Oral Cavities
时间窗: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study
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