Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zohaib Akram
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Probing depth
研究概览
简要总结
Purpose: To evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to non-surgical periodontal therapy on the clinical periodontal and biochemical parameters among patients with rheumatoid arthritis (RA) having periodontitis.
Methods: A total of 50 RA patients with periodontitis were included. The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively. Plaque score (PS), bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were estimated. The biochemical parameters included the assessment of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs). Multiple comparisons were established by employing the Bonferroni's post-hoc test for both clinical and laboratory biomarker data. The Mann-Whitney test was used to compute the p-value for intergroup comparisons. For intra-group comparisons, the p-value was computed with the help of Wilcoxon signed ranks test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥25 years
- •Satisfying the 2010 ACR/EULAR categorization criteria (with active RA with ≥6 joint involvement and under anti-RA medication ≥3 months)
- •Patients having >20 teeth diagnosed with generalized (>30% of sites) chronic periodontitis with PD ≥ 4mm and/or CAL ≥ 4mm and vertical bone loss of at least 4 mm on radiography.
排除标准
- •Patients who had underwent periodontal therapy or antimicrobial therapy in the last 6 months
- •Any joint replacement
- •Pregnancy/lactating mothers
- •Patients having other forms of systemic diseases such as diabetes mellitus, hypertension or acquired immunodeficiency syndrome (AIDS)
结局指标
主要结局
Probing depth
时间窗: 12 weeks
Measurement of consecutive millimeter markings of the periodontal pocket depth
Clinical attachment level
时间窗: 12 weeks
Measurement of periodontal pocket depth along with recession
次要结局
- Bleeding on probing(12 weeks)
- Interleukin-6(12 weeks)
- Tumor necrosis factor alpha(12 weeks)
- Plaque index(12 weeks)