CTRI/2025/09/095106尚未招募3 期
Clinical research study to evaluate the efficacy of a stannous fluoride toothpaste on established dental plaque and gingivitis in adults
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gingivitis (Loe and Silness Index)
研究概览
简要总结
The objective of this clinical research study is to evaluate the efficacy of a specialized toothpaste on established dental plaque and gingivitis in adults. This is a phase III, single center, randomized, parallel and double blinded study conducted on about 100 subjects in the age group between 18 to 70 years.
The subjects will be exposed to either of 2 different test products for a period of 6 months with a treatment regimen of whole mouth brushing twice daily for 2 minutes.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Potential subjects must meet ALL of the following criteria: Males and females, between 18-70 years of age; Informed Consent Form signed and availability for the duration of the study; Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study.
- •Examples include heart problems, valve/hip replacements, etc); Willingness to provide information related to their medical history; Minimum of 15 uncrowned permanent natural teeth (excluding third molars); Initial mean gingivitis index of at least 1 as determined by the use of the Loe and Silness Gingival Index and mean Plaque Index score of at least 1.5 determined by the Turesky modification of the Quigley-Hein Plaque Index; Availability for the duration of the study.
排除标准
- 未提供
结局指标
主要结局
Gingivitis (Loe and Silness Index)
时间窗: Baseline, 3 months and 6 months
次要结局
- Plaque (Turesky modification of the Quigley-Hein Plaque Index)(Baseline, 3 months and 6 months)
研究者
Dr Ashish Kakar
GLOBAL HEALTH RESERCH GROUP
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Comparing Aloe Vera Gel and Recaldent™ for Reducing Tooth Sensitivity in patients having Dentinal hypersensitivityCTRI/2025/07/090900Komal Eknath Gaikar52
已完成
不适用
Extrinsic Tooth Whitening Evaluation of a Whitening ToothpasteNCT07428603Church & Dwight Company, Inc.118
尚未招募
不适用
Comparison of different types of Band and loop space maintainersCTRI/2025/08/093713DrIccha Upadhyay45
招募中
不适用
Effect of Hydroxyapatite Toothpaste and Mouthwash in Preventing White Spot Lesions During Orthodontic TreatmentNCT07325643Heba Tahseen Almasri75
尚未招募
3 期
A Study Comparing Calcium Hydroxide, Bio-C Repair, and Calcimol-LC for Treating Deep Cavities in Lower First Molars”CTRI/2025/07/090864Dr Diksha kumari75