CTRI/2024/06/068516尚未招募不适用
Oral Health Assessment of an Adult Population in India
Colgate-Palmolive1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Oral health status, risk assessment, oral wellness, digital images
研究概览
简要总结
The study titled, "Oral Health Assessment of an Adult Population in India" is a single-centered observational study that will be conducted at the Colgate Clinical Innovation Institute, India Global Technology Center of Colgate-Palmolive (India) Limited in Mumbai, India. The study aims to enroll 300 healthy subjects in the age group of 18-70 years, where oral health screening and clinical research evaluations will be carried out to assess their oral health status, perform risk assessment, determine oral wellness and gather digital images.
研究设计
- 研究类型
- Observational
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 10 uncrowned permanent natural teeth (excluding wisdom teeth);.
排除标准
- •Potential subjects must NOT HAVE ANY of the following conditions:
- •Oral pathology, chronic disease, or a history of allergy to oral care products, teeth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
- •Presence of orthodontic appliances;
- •Obvious signs of periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study;
- •Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics;
- •Subject participating in any other clinical study that might interfere with the main study outcome;
- •Subject pregnant or breastfeeding;
- •Ongoing use of medications known to affect the gum tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);.
结局指标
主要结局
Oral health status, risk assessment, oral wellness, digital images
时间窗: Baseline
次要结局
- N/A(N/A)
研究者
Dr Bhuvana Gurumurthy
Colgate-Palmolive India Limited
研究点 (1)
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