Evaluation of the Post Treatment Pain After Instrumentation of Root Canals With a Single File Reciprocating (Wave-One Ni Ti File, DENTSPLY Maillefer) or Rotary(One Shape, Micro Mega, France) File System in Patient With Asymptomatic Necrotic Molars
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Post operative pain
研究概览
简要总结
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
详细描述
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
Sample
if the success rate (no pain) for wave one subjects is 0.3, we will need to study 17 patients in each group to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. the type 1 error probability associated with this test of this null hypothesis. This no is to be increased to total no 42 to compensate for losses during follow up , the sample size was calcukated by the PS program
Patients are recruited for the clinical trial from the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo University to meet the target sample size.
A random sequence will be generated by computer software, (http://www.random.org/) in the Center of Evidence Based Dentistry, Cairo University. This table will be kept with a co-investigator
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
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free patients
- •Patient's age between 25-50 years.
- •Mandibular molars diagnosed clinically as necrotic with normal apical tissues.
- •Positive patient's acceptance for participation in the study.
- •Both genders are included.
- •Patients able to sign informed consent.
- •Normal periodontal tissues.
- •Normal periapical tissues on the radiograph
排除标准
- •Patients with complicating systemic disease.
- •Having severe pain and/or acute apical abscesses.
- •Under the age of 25 years.
- •Patients using antibiotics or analgesic 12 hours before the procedures.
- •Having multiple teeth that required treatment.
- •With non-restorable and/or periodontally compromised teeth.
- •Retreatment cases
- •Presence of sinus tract
研究组 & 干预措施
OneShape
OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
干预措施: One-shape rotationary system (Other)
wave -one reciprocating system
The reciprocating single file systems WaveOne (Maillefer, Ballaigues, Switzerland) provide more flexibility of the M-wire Ni-Ti alloy, greater resistance to cyclic fatigue and better handling of narrow and curved canals than the traditional Ni-Ti instruments Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created.
The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal.
干预措施: One-shape rotationary system (Other)
结局指标
主要结局
Post operative pain
时间窗: changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10
Post operative pain after mechanical preparation with wave one and one shape using VAS scale from 0 to 10 Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment. The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation. The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows: 0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
次要结局
未报告次要终点
研究者
Ahmed Ragab Mohamed
master candidate at endodontic department faculty of oral and dental medicine CU
Cairo University