Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögren's Syndrome: XERODIAG
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Specificity
研究概览
简要总结
Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Its diagnosis mainly relies on the measurement of salivary flow (SF). Performing this test is unpleasant for the patient, lacks precision, can be influenced by certain conditions, and requires good patient cooperation. Other alternatives such as the buccal Schirmer test can be used. The aim of this study is to demonstrate the non-inferiority of the buccal Schirmer test compared to SF measurement. This is a diagnostic study comparing a group of patients (n=90) with Sjogren's syndrome (SS) and normal SF (≥0.1 ml/minute) to a group of patients with SS and decreased SF (<0.1 ml/minute).
详细描述
Introduction:
Xerostomia or dry mouth is a manifestation encountered in various physiological or pathological conditions. One of its main causes is Sjogren's syndrome, an autoimmune disease not specific to an organ, characterized by lymphoplasmacytic infiltration of autoimmune origin affecting mainly the salivary and lacrimal glands.
It is a debilitating condition leading to a significant impairment in quality of life primarily due to the dry mouth syndrome. Apart from the risk of corneal perforation caused by xerophthalmia, xerostomia is characterized by difficulty in chewing, swallowing especially dry foods, and speech. It is also associated with a risk of caries, dental decay, and fungal infections. Salivary flow measurement (SF) is the diagnostic method used to confirm xerostomia if it is less than 0.1 ml/minute. However, it is a test that is poorly accepted by the patient, lacks precision, can be influenced by test conditions, requires good patient cooperation, and is unpleasant for the healthcare provider.
The aim of our study is to demonstrate the non-inferiority of the buccal Schirmer test (BST) compared to SF measurement in patients with Sjogren's syndrome.
- Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included patients meet the following criteria:
- •age over 18 years
- •diagnosis of Sjogren's syndrome meeting the ACR/EULAR 2016 criteria.
排除标准
- •These include:
- •Cognitive or dementia disorders
- •Pregnancy
结局指标
主要结局
Specificity
时间窗: 30 minutes
ratio of the number of patients with BST- and SF- by the number of patients with SF-
Sensitivity
时间窗: 30 minutes
ratio of the number of patients with SF+ and BST+ by the number of patients with SF+
Positive predictive value
时间窗: 30 minutes
ratio of the number of patients with SF+ and BST+ by the number of patients with BST+
Negative predictive value
时间窗: 90 minutes
ratio of the number of patients with BST- and SF- by the number of patients with BST-
次要结局
未报告次要终点
研究者
Fatma Said
Associate professor
University Tunis El Manar