Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Clinical and radiographical success rates (%) of each treatment group
研究概览
简要总结
To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.
详细描述
The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
- •Positive response to EPT or cold test
- •patients willing to participate in study
- •Healthy subjects; absence of any systematic disorder
- •Age ≥ 10 years old
- •Both gender
- •Written informed consent
排除标准
- •Moderate or severe periodontitis; pockets >3mm
- •None restorable tooth
- •Internal or external root resorption
- •Root canal calcification
- •Non vital pulps
- •Analgesic taken within the last 8h
- •Active systemic disease
- •Pregnancy or nursing
- •History of opioid addiction/abuse
- •Temporary residency
研究组 & 干预措施
Indirect pulp capping (IPC)
Indirect pulp capping
干预措施: Indirect pulp capping (IPC) (Procedure)
Direct pulp capping (DPC)
Direct pulp capping
干预措施: Direct pulp capping (DPC) (Procedure)
Miniature pulpotomy (MP)
Miniature pulpotomy
干预措施: Miniature pulpotomy (MP) (Procedure)
Full pulpotomy (FP)
Full pulpotomy
干预措施: Full pulpotomy (FP) (Procedure)
结局指标
主要结局
Clinical and radiographical success rates (%) of each treatment group
时间窗: 1 year
The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection. The outcome of radiographic success is classified by using a modification of the Strindberg criteria.
次要结局
- Patient Assessment of Pain with questionnaire(6-months)
研究者
Saeed Asgary
Dean of ICER
Shahid Beheshti University of Medical Sciences