Strategic Inflammation Modulation and Advanced Regenerative Therapy of Dental PULP
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement Compare LXA4 and RvE1 levels in saliva, gingival crevicular fluid, and dental pulp in patients with dental pulpitis and healthy subjects.
研究概览
简要总结
This observational study aims to better understand inflammation inside the dental pulp (the inner tissue of the tooth) in patients with symptomatic pulpitis compared with healthy individuals.
Researchers will measure inflammation-related biomarkers in saliva, gingival fluid, and dental pulp samples to determine whether these substances reflect the level of inflammation.
The study also evaluates whether saliva and oral fluids could be used as simple, non-invasive tools to detect and monitor pulp inflammation.
We hypothesize that patients with pulpitis will show different biomarker levels compared with healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, male or female.
- •Patient consulting for symptomatic pulpitis (confirmed clinical and radiographic diagnosis) or for wisdom tooth extraction (healthy subject).
- •Patient able to understand the research and having signed a written consent form.
- •Permanent teeth only.
排除标准
- •Refusal to participate.
- •Pregnancy or breastfeeding.
- •Antibiotic or anti-inflammatory treatment in the week prior to sampling.
- •Clinically diagnosed inflammatory gingival or periodontal disease (gingivitis or periodontitis)
- •Chronic systemic inflammatory disease (e.g., uncontrolled diabetes, autoimmune diseases).
- •Patients under guardianship, conservatorship, or legal protection
研究组 & 干预措施
Patients with pulpitis
Sick group (patients with symptomatic pulpitis requiring endodontic treatment)
Healthy patients
Healthy group (healthy patients undergoing wisdom tooth extraction for orthodontic or prophylactic reasons)
结局指标
主要结局
Measurement Compare LXA4 and RvE1 levels in saliva, gingival crevicular fluid, and dental pulp in patients with dental pulpitis and healthy subjects.
时间窗: Day 0 (initial visit)
Average concentration of LXA4 and RvE1 (expressed in pg/mL or ng/mL) measured by mass spectrometry in each type of biological sample, compared between the pulpitis group and the healthy group.
次要结局
未报告次要终点
研究者
Alexis Gaudin
Professor
Université de Nantes