Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change of postoperative pain (Visual Analog Scale )
研究概览
简要总结
60 patients were divided into 2 groups, 30 patient in each group
Group I: Obturation with TotalFill BC Sealer using the single cone technique
Group II: Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique.
Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.
详细描述
Endodontic treatment will be performed in a single visit
Root canal preparation
- After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab.
- All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant.
- Cleaning and shaping of the canal will be performed using rotary ProTaper Next files (Dentsply, Maillefer) connected to an endodontic motor according to the manufacturer's instructions and recommendations.
- Irrigation with sodium hypochlorite will be always performed during instrumentation.
- After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points.
- Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups.
Root canal obturation
- This study will be a double blind randomized study.
- Group I: Using TotalFill BC Sealer, the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer. A ProTaper Next gutta percha cone (Dentsply, Maillefer) of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser.
- Group II: TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done. The depth of the heated plugger will be 5 mm less than the WL followed by back filling.
- After obturation, the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling.
- A postoperative radiograph will be taken
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free patients
- •Patients age between 20-50 years
- •Vital pulp as indicated by thermal or electric pulp test
- •No history of previously initiated root canal treatment among the treated tooth
- •Sufficient tooth structure for isolation
- •Teeth with mature apices
排除标准
- •Pregnancy or lactation
- •Medically compromised patients
- •Previous endodontic therapy of the tooth to be treated.
- •Teeth diagnosed with non-vital pulp.
- •Periodontally compromised teeth (teeth with periodontal probing depth more than 3mm).
- •Teeth with abnormal anatomy or calcified canals.
- •Teeth with caries below the bony level (non-restorable tooth).
- •Immature teeth with open apices.
- •Complications during treatment (file separation, ledges, perforation, etc.)
- •Overfilling (overextended beyond the radiographic apex) or short filling (more than 2mm of the radiographic apex)
- •Radiographic evidence of root resorption
- •Patients who could not follow the instructions to record the visual analog scale
研究组 & 干预措施
TotalFill BC Sealer
single cone technique with TotalFill BC Sealer
干预措施: single cone technique using TotalFill BC Sealer (Other)
TotalFill BC Sealer
single cone technique with TotalFill BC Sealer
干预措施: warm vertical compaction technique using TotalFill BC Sealer HiFlow (Other)
TotalFill BC Sealer HiFlow
warm vertical compaction technique with TotalFill BC Sealer HiFlow
干预措施: single cone technique using TotalFill BC Sealer (Other)
TotalFill BC Sealer HiFlow
warm vertical compaction technique with TotalFill BC Sealer HiFlow
干预措施: warm vertical compaction technique using TotalFill BC Sealer HiFlow (Other)
结局指标
主要结局
change of postoperative pain (Visual Analog Scale )
时间窗: postoperative pain at 6 hours
numerical (0-10)
次要结局
未报告次要终点
研究者
Hussein Amr Youssef Shoukry
Phd student-endodontic department
Minia University