Investigation of Temporomandibular Joint Function and Related Factors in Patients With Primary Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Fonseca Anamnestic Index (FAI)
研究概览
简要总结
Study Purpose The purpose of this observational study is to determine the prevalence of temporomandibular dysfunction (TMD) in individuals diagnosed with Sjögren's syndrome and to examine the relationship between disease activity and TMD.
The main question to be answered is: Is TMD more common in individuals with Sjögren's syndrome, and is there a relationship between disease activity and TMD?
Method Participants diagnosed with Sjögren's syndrome will be evaluated. The prevalence and severity of TMD will be examined along with mouth opening, head posture, and oral health parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Fonseca Anamnestic Index (FAI)
时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Assesses the severity of TMD. As the score increases, the TMD severity (none, mild, moderate, severe) worsens. (0-15: None, 20-45: Mild, 50-65: Moderate, 70-100: Severe)
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Evaluates disease activity. A high score (5 and above) indicates high disease activity. (The higher the average score, the more severe the symptoms of fatigue, pain, and dryness.)
次要结局
- Xerostomia Inventory(Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.)
- Oral Health-Related Quality of Life - UK Scale(Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.)
- Visual Analog Scale (VAS) for Disease Involvement(Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.)
研究者
Begüm AKAR
Principal investigator
Pamukkale University