Comparative Evaluation of Postoperative Pain,Periapical Damage and Bacterial Disinfection After Using Endodontic Needle and Eddy Tips During Root Canal Irrigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of postoperative pain change during the first 48 hours after treatment
研究概览
简要总结
This investigation will focus on the use of EDDY tips, because it is known that the complete debridement of the canal is very difficult, which leads to an accumulation of tissue debris, bacteria and their products, resulting in persistent periradicular inflammation. So, it's of great importance, the study of other approaches of cleaning and disinfecting the root canal, which at the same time, may produce a lower risk of postoperative pain.
The above mentioned topics have never been analysed simultaneously with the use of EDDY tips, and the evaluation of the postoperative pain was never addressed.
This research is of great clinical interest, due to the complexity of root canal system, with isthmuses, ramifications and dentinal tubules, that make the total elimination of bacteria impossible, even with the best clinical protocols, because the irrigants cannot penetrate the dentinal tubules, and the postoperative pain is an exhausting factor for patients.
Therefore, a new protocol, with better disinfection rate and less postoperative pain, will be able to increase the success rate of endodontic treatments, allowing to save condemned teeth.
详细描述
CLINICAL STUDY:
- Rate of postoperative pain of 2 endodontic disinfection protocols.
-A clinical study will be carried out, in patients that attend the Faculdade de Medicina Dentária Dental Clinic at Universidade do Porto, for initial nonsurgical root canal treatments. About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.
Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease. Those patients will be divided in 2 groups: Group 1: (control group) 5,25% NaOCl with syringe needle irrigation alone. Group 2: 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)
All the patients will receive anaesthetic solution and after anaesthesia, each tooth will be isolated using rubber dam and the access cavity will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The patients will not know which treatment they will receive
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.
排除标准
- •Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease.
研究组 & 干预措施
Group 1
5,25% NaOCl with syringe needle irrigation alone
干预措施: 5,25% NaOCl with syringe needle irrigation alone (Drug)
Group 2
5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)
干预措施: EDDY (Device)
结局指标
主要结局
Evaluation of postoperative pain change during the first 48 hours after treatment
时间窗: first 48 hours after treatment
All patients will receive a paper with a visual analogue scale, to score their pain from 0 to 10. None of the patients will have analgesics prescribed immediately after the treatment. They will be advised to not take any medication at any point of the follow-up. If they need some advice or analgesic medication, they will be able to contact with the investigator. The investigator will reach the patients after 8, 24 and 48 h, in order to ask their pain intensity and to ask if they need to take any analgesic to stop the pain. In case of any patient mentioning an important pain, it will be advised to take Ibuprofen 600mg every 6 hours, until the pain disappears. If any patient is allergic to non-steroidal anti-inflammatories, they will be advised to take paracetamol 1g and not take more than 4g per day. All the controls will be recorded on each patient's chart.
次要结局
未报告次要终点