NCT02056262已完成不适用
Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 6
- 主要终点
- Bacterial profile
研究概览
简要总结
The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments of the Nîmes University Hospital and the Montpellier University Hospital.
详细描述
Secondary objectives include:
- Compare the distribution of bacterial species in relation to stages of severity of caries
- Compare the results from plaque with those of saliva samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers aged 3 to 45 who come in to the hospital for a dental consultation
- •Minors must have parental permission
- •The patient must have given his/her informed and signed consent
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is pregnant, or breastfeeding
- •The patient has been on antibiotics within the past two months
- •Teeth under current care
- •Parodontopathy
- •Use of a mouthwash within the last week
- •Insufficient numbers of healthy and/or teeth with carious lesions for carrying out the study
结局指标
主要结局
Bacterial profile
时间窗: Baseline (day 0)
Bacterial profiles will be constructed using saliva and plaque samples.
ICDAS assessment
时间窗: Baseline (day 0)
Dental caries will be assessed using the ICDAS (International Caries Detection and Assessment System) system
次要结局
- Within the last 12 months, the patient has had dental care or tooth removal following the carious lesion? yes/no(baseline (day 0))
- The patient has at least one carious lesion attacking the dentin or pulp. yes/no(baseline (day 0))
- The patient has at least one carious lesion reaching dentin or pulp on an anterior tooth or on the smooth surface of a posterior tooth (yes/no)(baseline (day 0))
- Does the patient have at least five fillings? yes/no(Baseline (day 0))
- Yesterday, did the patient eat at least three snacks (or sugary or carbonated drinks) between meals? yes/no(Baseline (day 0))
- Yesterday, did the patient brush his/her teeth fewer than 2 times? yes/no(baseline (day 0))
- The patient has at least one carious lesion restricted to the enamel? yes/no(baseline (day 0))
- The patient has at least one carious lesion restricted to the enamel on an anterior tooth or involving the smooth surface on a posterior tooth (yes/no)(baseline (day 0))
- Does the patient have at least one filling and one missing tooth on the anterior sector following the carious lesion? yes/no(baseline (day 0))
- Studies were stopped during high school? yes/no(baseline (Day 0))
研究者
研究点 (6)
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