A clinical study to evaluate the efficacy and safety of test product in providing teeth whitening benefits over 2 weeks
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1. Change in tooth shade from baseline as measured by the Linear shade guide using visual assessment by a dental professional.
研究概览
简要总结
This monocentric, comparative efficacy and safety study evaluates a novel dissolvable whitening strip designed to reduce surface stains and enhance tooth whiteness. The study aims to assess both clinical (objective) and user-reported (subjective) improvements in tooth shade, identify the onset of visible results, evaluate oral safety (including sensitivity or irritation), and gather detailed user feedback over 14 days. Participants will undergo screening, consent, and baseline assessments, including tooth shade evaluations, oral examinations, and questionnaires. Oral assessments, shade measurements, and feedback collection will be repeated at each visit, with compliance tracked through subject diaries. The final visit includes end-of-study evaluations and completion of the exit form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged 18–50 years.
- •Willing and able to comply with study procedures.
- •Provide signed informed consent.
- •Subjects having all anterior tooth.
排除标准
- •Trial participants having received professional scaling or bleaching treatment or having used over-the-counter teeth whitening products within one month of baseline visit.
- •Participants with A1, B1 and C1 tooth shades.
- •Individuals with any pre-existing dental conditions that could influence whitening outcomes or compromise safety (tetracycline stains, fluorosis etc.)
- •Trial participants with sensitive tooth.
- •Trial participants having periapical lesion, cavities, periapical lesion, rcts, periodontitis, or any other conditions that may affect the study as per investigators discretion.
- •Trial participants having prosthetic crowns or bridges on anterior part or any other prosthetic tooth replacement.
- •Trial participants having ortho treatment or wearing braces.
- •Trial participants using whitening toothpaste.
- •Female Trial participants who are pregnant, lactating or nursing (self declared).
- •Trial participants with any diseases or conditions that might interfere with the safe participation in the study.
- •Trial participants unable to undergo study procedures.
- •The trial participant is an employee of the Sponsor or the site conducting the study.
结局指标
主要结局
1. Change in tooth shade from baseline as measured by the Linear shade guide using visual assessment by a dental professional.
时间窗: Days 1, 3, 5, 7, and 14
2. Change in tooth shade from baseline, as measured by the VITA Easyshade® V.
时间窗: Days 1, 3, 5, 7, and 14
次要结局
- To evaluate participant-perceived changes in tooth whiteness using a self-assessment questionnaire at all study time points.
- To evaluate overall participant satisfaction with the product based on responses collected through a standardized self-assessment questionnaire across all time points.(Days 1, 3, 5, 7, and 14)
- To evaluate the perceived impact of the purple tint, including reduction in visible yellowness, concealment of stains, and immediate brightness enhancement, using participant responses collected through self-assessment questionnaires at each time point.(Days 1, 3, 5, 7, and 14)
- To evaluate the usability and ease of use of the product, including clarity of instructions, convenience of application, and user-friendliness, through participant feedback collected at all time points.(Days 1, 3, 5, 7, and 14)
- To evaluate the sensory experience of the product, including taste, comfort during application, and dissolution rate, using responses from a sensory feedback questionnaire.(Days 1, 3, 5, 7, and 14)
- To evaluate product palatability based on participant ratings collected through self-assessment questionnaires at multiple time points.(Days 1, 3, 5, 7, and 14)
- To evaluate the sensitivity of the tooth by self-perceived questionnaire.(Days 1, 3, 5, 7, and 14)
- Incidence of adverse oral events such as gum irritation, oral lesions, or discomfort observed during Oral Soft and hard tissue Tissue exams at each study visit.(Days 1, 3, 5, 7, and 14)
- Investigator assessments of the product’s overall tolerability throughout the study period.(Days 1, 3, 5, 7, and 14)
- Participant assessments of the product’s overall tolerability throughout the study period.(Days 1, 3, 5, 7, and 14)
研究者
Dr Lakshmi Chandrasekaran
MS Clinical Research Pvt. Ltd