Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 615
- 试验地点
- 1
- 主要终点
- Clinical and radiographical success of pulpotomy with CEM cement
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.
详细描述
In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit.
In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic criteria:
- •Patient reports pain of endodontic origin
- •Diagnosis of irreversible pulpitis
- •Eligibility criteria:
- •Molar tooth
- •Patient chooses to have tooth extraction for pain relief
- •Age 9-65 years
- •Both gender
- •The patient had read and thoroughly understood the questionnaires; and
- •Written informed consent
排除标准
- •Moderate or severe periodontitis
- •None restorable tooth
- •Internal or external root resorption
- •Root canal calcification
- •No bleeding after access cavity preparation
- •Analgesic taken within the last 4 h
- •Active systemic disease
- •The patient was pregnant or nursing
- •History of opioid addiction or abuse
- •Temporary residency
研究组 & 干预措施
1
ORCT
干预措施: One-visit root canal therapy (Procedure)
2
PCEM/PMTA
干预措施: pulpotomy (Procedure)
结局指标
主要结局
Clinical and radiographical success of pulpotomy with CEM cement
时间窗: 5 year
次要结局
- Patient Assessment of Pain - Visual Analogue Scale(7 day)
研究者
Saeed Asgary
Dean, Iranian Center foe Endodontic Research
Shahid Beheshti University of Medical Sciences