The Relationship Between Pulpal Biomarker Levels and the Success of Vital Pulp Therapy: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical success of treated teeth with Vital Pulp Therapy
研究概览
简要总结
This prospective clinical study aims to evaluate the association between the levels of selected pulpal biomarkers and the clinical success of vital pulp therapy in permanent teeth. Patients undergoing vital pulp therapy will be monitored over time, and biomarker expression levels will be analyzed in relation to treatment outcomes. The study intends to provide insight into the predictive value of pulp tissue biomarkers for long-term success in vital pulp procedures.
详细描述
The aim of this study is to identify the biomarkers that influence the success of vital pulp therapy (VPT), a treatment that offers several advantages over conventional root canal therapy. The study also aims to evaluate the success of VPT in teeth diagnosed with irreversible pulpitis. The success of VPT largely depends on the accurate assessment of pulpal status.
This prospective clinical study will be conducted on 50 patients who apply to the Department of Endodontics, Faculty of Dentistry, Atatürk University, and meet the inclusion criteria. Informed consent will be obtained from all participants. A specially designed clinical assessment form will be completed for each patient to record clinical findings prior to the procedure.
Local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Following anesthesia, the teeth will be isolated using a rubber dam. Caries removal will be performed under an operating microscope (OPMI) using a diamond bur and aerator. All infected dentin will be removed selectively until hard dentin is reached.
Pulpal bleeding will be controlled by applying a cotton pellet moistened with sterile saline into the cavity for one minute. Subsequently, pulpal fluid and blood samples will be collected using 5 mm-long sterile paper points to ensure equal sample volume per case. Each sample (one per patient) will be transferred into separate sterile Eppendorf tubes containing 500 µL of phosphate-buffered saline (PBS) and stored at -80°C until biochemical analysis. Total bleeding time will be recorded using a chronometer.
The first tube will be used for the analysis of mediators including RANTES (CCL5), MCP-1, TNF-α, TGF-β, IL-1β, TIMP-1, MMP-12, and MMP-1. The second tube will be used to measure MDA, SDA, TAS, and TOS levels.
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
- Single (Participant)
盲法说明
Participants were blinded to their group assignment, but investigators were aware of the clinical group classification.
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent teeth diagnosed with reversible pulpitis
- •Patients diagnosed with irreversible pulpitis but without apical radiolucency
- •Teeth showing a normal response to cold testing (carbon dioxide snow)
- •Teeth with irreversible pulpitis demonstrating prolonged response to cold testing
- •Teeth with no sensitivity to percussion or chewing
- •In teeth with exposed pulp tissue, bleeding time less than 5 minutes
- •In irreversible pulpitis cases, bleeding time less than 10 minutes
- •No widening of the periodontal ligament space (periapical index [PAI] ≤ 2)
- •Radiographic evidence of deep dentinal caries
排除标准
- •Teeth with a negative response to cold testing (carbon dioxide snow)
- •Presence of apical radiolucency (PAI > 2)
- •Condensed apical periodontitis
- •Internal or external root resorption
- •History of dental trauma
- •Longitudinal root fracture
- •Presence of periodontal-endodontic lesions on the day of treatment
- •Functional loss (e.g., Grade 3 tooth mobility)
- •Swelling associated with the treated tooth
- •Teeth that cannot be treated under rubber dam isolation
- •Teeth from which less than 2.5 mL of pulpal blood can be collected
- •Immunocompromised individuals
- •Pregnant women at the time of treatment
- •Use of antibiotics, bisphosphonates, or statins within 4 weeks prior to treatment
结局指标
主要结局
Clinical success of treated teeth with Vital Pulp Therapy
时间窗: 6-12 months after treatment
Clinical and radiographic success will be defined as the absence of symptoms (e.g., spontaneous pain, swelling), no sinus tract, no pathological mobility, and no periapical radiolucency. In addition, a positive response to pulp vitality tests (e.g., cold test or EPT) will be considered as an indicator of maintained pulpal vitality.
次要结局
未报告次要终点
研究者
ertuğrul karataş
Associate Professor of Endodontics
Ataturk University