Effect of Submucosal Corticosteroid Injection on Inflammatory Biomarkers and Postoperative Pain in Patients With Symptomatic Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gingival Crevicular Fluid Matrix Metalloproteinase-9 (MMP-9) Concentration
研究概览
简要总结
This randomized clinical trial compared standard single-visit root canal treatment with adjunctive submucosal betamethasone and gentamicin in 100 patients with symptomatic irreversible pulpitis, assessing postoperative pain and inflammatory biomarkers (IL-1β, MMP-9, and RANKL).
详细描述
This study was designed as a prospective, randomized controlled clinical trial. A total of 100 patients with a VAS pain score ≥7 and SIP in posterior teeth were included. Participants were randomly assigned into two groups: a standard root canal treatment group (n = 40) and an adjunctive treatment group receiving submucosal betamethasone and gentamicin (n = 60). In all cases, conventional single-visit root canal treatment was performed. Gingival crevicular fluid (GCF) samples were collected preoperatively and on postoperative day 3, and VAS scores were recorded at the same time points. Levels of IL-1β, MMP-9, and RANKL in GCF samples were quantified using enzyme-linked immunosorbent assay (ELISA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Patients diagnosed with symptomatic irreversible pulpitis
- •Presence of spontaneous pain or pain persisting after removal of the stimulus
- •Teeth indicated for endodontic treatment
- •Systemically healthy individuals
- •Patients able to read and sign the informed consent form
- •Patients able to complete postoperative pain assessment forms
- •Patients able to attend the 4-day follow-up visit
排除标准
- •Individuals with systemic disease or immunosuppression
- •Patients with contraindications to corticosteroid or gentamicin use
- •Pregnant or breastfeeding individuals
- •Recent use of antibiotics, analgesics, or anti-inflammatory drugs
- •Presence of advanced periodontal disease in the affected tooth
- •Presence of acute periapical or periodontal abscess
- •Teeth with previous endodontic treatment
结局指标
主要结局
Gingival Crevicular Fluid Matrix Metalloproteinase-9 (MMP-9) Concentration
时间窗: Baseline and post-treatment day 3
MMP-9 levels in gingival crevicular fluid will be quantified using enzyme-linked immunosorbent assay (ELISA).
次要结局
未报告次要终点
研究者
Seyda Ersahan, DDS, PhD
Principal Investigator, Clinical Associate Professor
Istanbul Medipol University Hospital