Prevalence and Characteristics of Dental and Periodontal Lesions in Patients With Sjögren's Syndrome. Establishment of a Biological Saliva Collection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome
研究概览
简要总结
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands.The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been shown in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, although this has not been clearly identified in the literature.
Our main objective is to assess the prevalence of dental wear and gingival recession in patients with Sjögren's syndrome by analyzing of the Basic Erosive Wear Examination (BEWE) score for erosions, Basic Erosive Wear Abrasion (BEWA) score for attrition and percentage of sites with periodontal recessions greater than 3 mm in relation to the total number of sites.
Our secondary objectives are to investigate a correlation between the prevalence of dental and gingival wear, gingival inflammation, Decayed, Missing, and Filled Teeth (DMFT) index and (1) salivary parameters and (2) oral quality of life.
The salivary samples will be kept in a biological collection within the URP2496 for later analysis (biological collection CB-SJO).
详细描述
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands leading to hyposiala. The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been described in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, but not clinical attachment loss, although this has not been clearly identified in the literature.
The present research focuses on the characterization of tooth wear and gingival recession prevalence in patients with Sjögren syndrome. A correlation of this parameters with salivary parameters (Xerostomia Inventory to assess the dryness, unstimulated salivary rate, stimulated salivary rate, pH and buffer capacity) will be assessed.
The salivary samples will be kept in a biological collection within the URP2496 for later cross-sectional research purposes to identify salivary changes associated with increased risk of dental wear, dental caries, periodontal wear or periodontal inflammation (biological collection CB-SJO).
This is a descriptive, prospective, open-label, non-interventional, single-center study with collection of salivary samples (CB-SJO) from a sample of patients with Sjögren's disease as part of the patient's routine care.
Patients will be recruited in the oral medicine department of the AP-HP Charles Foix hospital (Ivry/seine).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Sjögren Syndrome
- •Patient > 18 years old
- •Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME
- •Patient who speaks and understands French well enough to be able to read and understand the study information note.
- •Patient who does not object to his participation in the study
排除标准
- •Patient having expressed his opposition to participate in the research
结局指标
主要结局
Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome
时间窗: Once a year for 5 years
BEWE score, BEWA score, Percentage of sites with periodontal recessions greater than 3 mm of the total number of sites
次要结局
- Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of life(Once a year for 5 years)
- Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life.(Once a year for 5 years)
- Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life(Once a year for 5 years)