NCT01750528已完成不适用
The Prevalence and the Progression of Periodontitis in Ankylosing Spondylitis (AS) Patients Versus Non-AS Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- prevalence rate of periodontitis
研究概览
简要总结
- Our hypotheses on the relationship between periodontitis and AS are as follows;
- The prevalence of periodontitis is higher in AS patients group than that of non-AS control group
- Anti-TNF-α therapy would favorably affect the disease course of periodontitis.
- Based on our hypotheses, the specific objectives of the present proposal are as follows;
-
The primary objective is to compare the prevalence rate of periodontitis between AS patient group and non-AS group.
-
The secondary objectives will be:
-
To observe the carriage rate of P. gingivalis in AS and non-AS groups
-
To identify clinical parameters associated with the severity of periodontitis in AS group.
-
To compare the progression of periodontitis at weeks 12 and 24 between AS and non-AS groups or between AS patients with and without anti-TNF-α treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Subjects giving informed written consent
- •In case of AS patients, subjects to meet the 1984 modified New York criteria for AS.
- •In case of controls, subjects without a history of inflammatory arthropathy
排除标准
- •Subjects having received periodontitis treatment including scaling within 6 months before study participation.
- •Subjects with a history of taking antibiotics including prophylactic anti-tuberculosis agents within 3 months before study participation.
- •Subjects with a hitory of taking immuno-suppresives (methotrexate, leflunomide, tacrolimus, cyclosporin, or azathioprine) or any dose of glucocorticoids (oral or pareneral) within 3 months before study participation.
- •Subjects with a history of diabetes mellitus.
- •Subjects with aggressive periodontitis requiring open flap debriment at enrollment immediately.
- •Subjects with a hitory of clinical inflammatory bowel disease.
- •Subjects with active infection, which can make an influence on the levels of acute phase reactants.
- •Subjects with any other condition to render the patient unable to understand the scope of the study or preclude the patient from following the protocol in the physician's opinion.
结局指标
主要结局
prevalence rate of periodontitis
时间窗: At enrollment
次要结局
- carriage rate of P. gingivalis(At enrollment)
- progression of periodontitis(12 and 24 week)
研究者
Yun Jong Lee
Associate Professor
Seoul National University Bundang Hospital
研究点 (1)
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