CTRI/2025/06/089500尚未招募不适用
To study and understand the oral microbiome and its diversity in the Indian population.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The samples collected will be studied in different phases (genomics and transcriptomics)
研究概览
简要总结
This is an observational clinical study to study and understand the oral microbiome and its diversity in the Indian population. Hundred (100) subjects, aged 18-55 years, inclusive, will be entered into the study. Candidates who have expressed an interest in participating will be selected based on the inclusion and exclusion criteria. This is an observational, single-center, single arm clinical study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Potential subjects must meet ALL of the following criteria: Males and Females, between age
- •55, inclusive. Good oral health with no evidence of untreated dental decay or active periodontal disease at the point of sample collection. Subjects will be screened by the dental examiner Willingness to refrain from oral care hygiene for 12 hours prior to sample collection and refrain from eating, drinking (other than water) 4 hrs prior to sample collection. Signed Informed Consent Form.
排除标准
- •Potential subjects must NOT HAVE ANY of the following conditions: Hepatitis B or C, HIV infection, oral herpes (cold sore), sinusitis, etc.).
- •Premedication required for dental procedures.
- •Pregnant or breastfeeding.
- •Current or history of infectious disease (i.e. Current contagious illness (i.e. upper respiratory Subject allergic to oral care products or their ingredients.
- •Use of antibiotics any time during or three months prior to entry into the study.
- •Use of therapeutic oral care products within 1 month prior to entry into the study.
- •Abnormal salivary function including medication induced dry mouth Diseases of the soft or hard tissue of the oral cavity Five (5) or more decayed untreated dental sites at screening Active periodontal disease (ie purulent exudate or tooth mobility), or having received periodontal treatment (ex: SRP- scaling and root planing) 6 months before entering study Current smokers or use of tobacco or vaping products Subjects using anticonvulsants, antihistamines, antidepressants, steroids, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study Subjects wearing removable retainers, dentures or with fixed orthodontic appliances.
结局指标
主要结局
The samples collected will be studied in different phases (genomics and transcriptomics)
时间窗: After Donation in Visit 2 samples will be sent to Genotypic for assessment
次要结局
未报告次要终点
研究者
研究点 (1)
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