Effect of Nonsurgical Periodontal Treatment on Gingival Crevicular Fluid Calprotectin and IL-10 Levels in Patients With Rheumatoid Arthritis and Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Gingival Crevicular Fluid Calprotectin (MRP-8/14) Levels
研究概览
简要总结
This study evaluates the relationship between rheumatoid arthritis and periodontal health and examines the effects of nonsurgical periodontal treatment on clinical periodontal findings and gingival crevicular fluid biomarkers. Participants with and without rheumatoid arthritis were classified according to periodontal status as periodontally healthy, gingivitis, or periodontitis. Clinical periodontal measurements and gingival crevicular fluid levels of calprotectin (MRP-8/14) and interleukin-10 (IL-10) were evaluated at baseline, 1 month, and 3 months. Disease Activity Score-28 (DAS28) was also evaluated in participants with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation in the study. Aged 18 to 65 years. For participants in the rheumatoid arthritis groups, diagnosis of rheumatoid arthritis at least 1 year before enrollment.
- •For participants in the systemically healthy groups, absence of any systemic disease that may affect periodontal tissues.
- •No periodontal treatment within the previous 6 months. No local or systemic antibiotic use within the previous 3 months. Never having smoked or having stopped smoking at least 2 years before enrollment.
- •For participants in the periodontally healthy control groups, no history of periodontal disease and the presence of good oral hygiene.
排除标准
- •Unwillingness to participate in the study. Age younger than 18 years or older than 65 years. Presence of any systemic disease other than rheumatoid arthritis that may affect periodontal tissues.
- •Local or systemic antibiotic use within the previous 3 months. Periodontal treatment within the previous 6 months. Pregnancy or lactation. Use of medications that may affect gingival tissues, including calcium channel blockers, phenytoin, cyclosporine, or hormone replacement therapy.
- •Receiving biological treatment for rheumatoid arthritis, such as anti-tumor necrosis factor therapy.
- •Current smoking.
研究组 & 干预措施
Periodontitis with Rheumatoid Arthritis (P+RA
Participants with rheumatoid arthritis and periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants.
干预措施: Non-surgical Periodontal Treatment (Procedure)
Systemically Healthy Participants with Periodontitis (P)
Systemically healthy participants with periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants.
干预措施: Non-surgical Periodontal Treatment (Procedure)
Gingivitis with Rheumatoid Arthritis (G+RA)
Participants with rheumatoid arthritis and gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants.
干预措施: Non-surgical Periodontal Treatment (Procedure)
Systemically Healthy Participants with Gingivitis (G)
Systemically healthy participants with gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants.
干预措施: Non-surgical Periodontal Treatment (Procedure)
Periodontally Healthy Participants with Rheumatoid Arthritis (S+RA)
Participants with rheumatoid arthritis and periodontal health receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants.
Systemically Healthy Participants with Periodontal Health (S)
Systemically and periodontally healthy participants receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants.
结局指标
主要结局
Change in Gingival Crevicular Fluid Calprotectin (MRP-8/14) Levels
时间窗: Baseline, 1 month, and 3 months
Gingival crevicular fluid calprotectin (MRP-8/14) levels were measured using an enzyme-linked immunosorbent assay (ELISA). Changes in calprotectin levels were evaluated over time and compared according to rheumatoid arthritis status and periodontal condition.
次要结局
- Change in Gingival Crevicular Fluid Interleukin-10 (IL-10) Levels(Baseline, 1 month, and 3 months)
- Change in Probing Pocket Depth(Baseline, 1 month, and 3 months)
- Change in Clinical Attachment Level(Baseline, 1 month, and 3 months)
- Change in Bleeding on Probing(Baseline, 1 month, and 3 months)
- Change in Plaque Index(Baseline, 1 month, and 3 months)
- Change in Gingival Index(Baseline, 1 month, and 3 months)
- Change in Gingival Crevicular Fluid Volume(Baseline, 1 month, and 3 months)
- Change in Disease Activity Score-28 (DAS28)(Baseline and 3 months)
研究者
Songül Bingöl
Research Assistant, Department of Periodontology, Faculty of Dentistry
Ondokuz Mayıs University