CTRI/2025/03/082282招募中2 期
A double blind, single centric, randomized 3 arm parallel study to evaluate the efficacy and safety of Gurunanda Whitening mouthwash with enzymes in the management of improvement in tooth shade, reduction of surface stains and prevention of new stains
GURUNANDA1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement of tooth whitening
研究概览
简要总结
This is a randomized, double blind, placebo controlled, 3 arm parallel study in single center.
This study is to assess the teeth whitening effectiveness and safety of active when compared to comparator and placebo. Study is planned to be conducted in a clinical site where EC is registered with CDSCO. Study will be only initiated after receiving CTRI registration number.
Based on inclusion/exclusion criteria subjects with teeth shade of more than A2 will be randomised into the trial. The study population is 120 subjects, 40 subjects on active, 40 subjects on comparator and 40 subjects on placebo. The duration of the study is 6 weeks from baseline with 5 visits.
The study outcome are;
Primary outcome - Improvement of teeth whitening.
Secondary outcome - Reduction of surface stain and Prevention of new stain.
Study design - Randomized, double blind, placebo controlled 3 arm study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male or female subjects 2.Subjects with atleast 20 permanent teeth excluding third molar 3.Non-smokers with good oral and general health 4.All 6 anterior maxillary teeth free of caries or restorations 5.Subjects having teeth shades of A2 or darker with no cervical lesions or prosthodontics treatments and with no periodontal disease 6.Subjects should not use mouthwash 1 week prior to screening and during the whole course of the study 7.All subjects should use same toothpaste during the entire course of the study 8.Able to communicate adequately with the investigator and to comply with the requirements for the entire study 9.Subjects should not have history of periodontal therapy one month prior to screening 10.Patient should be able to give written informed consent prior to participating in the study 11.Will not use other teeth whitening product(s) during the duration of the study.
排除标准
- •1.Individuals with discolored teeth (eg:- tetracycline and fluorosis).
- •2.Subjects having intrinsic stains.
- •3.Steroidal anti-inflammatory drugs, NSAIDs one month prior to screening.
- •4.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases).
- •5.Subjects with known sensitivity or oral mucosal tissue reaction to any components of the investigational product.
- •6.Pregnancy and breastfeeding women.
- •7.Participation in concomitant interventional clinical study during the previous 30 days.
- •8.Active oral infections, untreated cavities, or periodontal disease.
- •9.Presence of restorations on front teeth (e.g., crowns, veneers, or composite fillings) that could affect whitening results.
- •10.Recent dental procedures (e.g., scaling, polishing, or whitening) within the last 4 weeks.
- •11.Concurrent use of whitening products or treatments within the past 4 weeks.
- •12.Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
- •13.Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
- •15.Presence of orthodontic appliances, except for removable retainers.
- •16.Signs of advanced enamel wear, dentin exposure, or tooth fractures.
结局指标
主要结局
Improvement of tooth whitening
时间窗: Screening, week 2,4 and 6.
次要结局
- 1) Reduction of surface stains(2) Prevention of new stain)
研究者
研究点 (1)
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