Comparative Evaluation of Postoperative Pain After Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis of Mandibular Premolar Teeth
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 主要终点
- postoperative pain
研究概览
简要总结
the aim in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with symptomatic irreversible pulpits.
According to the inclusion criteria the patients enrolled in the study and allocated randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is done at single visit. firstly the patient's medical and dental history is taken .the patient assign on informed consent. and then,anaesthetized and access cavity performed and root canal preparation is done by either two systems and then irrigation and obturation is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator will recall the patient to check the records and follow up the patient.
详细描述
Medical and dental history: diagnostic charts will be collected in a case report form by the investigators and confirmed for eligibility with the assistant supervisor.
Radiographic examination : preoperative radiographs will be taken to examine the tooth structure,caries detection , periapical status .
Clinical examination : intraoral examination include visual examination for caries , restoration ,swelling ,fistula . mobility, percussion were done .
Diagnostic criteria for symptomatic irreversible pulpitis:
- The patient marks moderate to severe pain on the numerical rating scale (NRS) . a horizontal line of 11 marks and 10 intervals each takes numbers from 0 to 10 where 0 = no pain , 1-3 =mild pain , 4-6 = moderate pain , 7-10 = severe pain (recording the baseline degree of pain preoperatively before initiating the endodontic treatment ) all the steps done by the same operator.
- The patient shows severe pain which lasts long after thermal testing which is done by applying hot compound stick on the tooth after coating it with a lubricant.
- The patient responds to electric pulp tester at a lower level than the contralateral tooth or the adjacent tooth if the contralateral one is missing.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in good health(American Society of Anesthesiologists Class II or higher).
- •Patients having symptomatic irreversible pulpitis in one of their mandibular premolars.
- •Age range is between 20 and 35 years.
- •Patients who can understand numerical rating scale (NRS).
- •Patients able to sign informed consent.
排除标准
- •Patients with positive percussion test .
- •Patients having history of necrosis with or without apical pathosis .
- •Patients have sinus tract or fistula extraoral or intraoral.
- •Patients having active pain in more than one pre molar.
- •Patients who had taken analgesics in the 12 hours preceding the preparation.
- •Pregnant or mentally retarded patients.
- •Teeth with grade 2 or 3 mobility.
研究组 & 干预措施
neolix
single full rotation file (Neolix ® Neolix ,France) the first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal
干预措施: neolix (Procedure)
wave one
single reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal
干预措施: wave one (Procedure)
结局指标
主要结局
postoperative pain
时间窗: up to 48 hours after completion of treatment
intensity of postoperative pain after treatment by Numerical Rating Scale (0-10)
次要结局
未报告次要终点
研究者
Yasmin hassan youseif
resident at endodontic department faculty of oral and dental medicine CU
Cairo University