Efficacy of Metabolic Biomarkers in Predicting Twelve-Month Outcomes of Vital Pulp Treatment in Symptomatic Teeth With Carious Pulp Exposure: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pulp survival: is overall clinical success at 12 months
研究概览
简要总结
This prospective controlled clinical trial investigates whether metabolic biomarkers measured in pulpal blood at the time of carious pulp exposure can predict the 12-month outcomes of vital pulp treatment in symptomatic permanent teeth. Eligible patients aged 16-50 years presenting with deep carious pulp exposure will undergo vital pulp therapy (partial pulpotomy or full pulpotomy). Pulpal blood samples will be collected at the time of exposure and analyzed using High-Performance Liquid Chromatography (HPLC). Treatment outcomes will be assessed clinically and radiographically at 12 months. The study aims to identify objective, measurable biomarkers that can improve pulpal diagnosis and guide clinical decision-making in vital pulp therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The lab personnel who will perform the biomarker measurement test (HPLC)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range of 16-50 years.
- •Pulp exposure during treatment of deep caries.
- •Absence of periodontitis or systemic disease.
- •Only one or two proximal surfaces lost with remaining walls > 2 mm; and
- •Good compliance and signed informed consent forms.
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •Teeth with unrestorable large defects or the need for RCT for aesthetic reasons;
- •Teeth with a negative response to cold testing
- •Current pregnancy or breastfeeding;
- •Poor compliance or inability to complete the trial.
- •The use of medications, including antibiotics, bisphosphonates, or statins, within 3 weeks before the study.
- •Inadequate blood sample collection after pulpal exposure.
研究组 & 干预措施
Vital Pulp Treatment (VPT)
Participants with symptomatic teeth and carious pulp exposure will receive vital pulp treatment after caries removal. The specific procedure will be determined intraoperatively based on clinical criteria. Pulpal blood samples will be collected for metabolic biomarker analysis, followed by placement of a calcium silicate-based material and definitive restoration. Clinical and radiographic outcomes will be assessed over 12 months.
干预措施: vital pulp treatment (Procedure)
Control Arm: Healthy Reference Group (No Treatment)
Teeth without pulp pathology, extracted for orthodontic reasons, will serve as the control group. Pulpal blood samples will be collected for metabolic biomarker analysis. No therapeutic intervention or follow-up will be performed.
结局指标
主要结局
Pulp survival: is overall clinical success at 12 months
时间窗: From enrollment to the end of 12 months follow-up
Pulp survival: is overall clinical success at 12 months, defined according to COS-ENDO domains as the absence of patient-reported pain, absence of clinical signs of infection, maintenance of normal periradicular status radiographically, preservation of functional tooth structure, and no need for further intervention.
次要结局
未报告次要终点
研究者
Abeer Ghalib Abdul-khaliq
Dr.
University of Baghdad