Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
- The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis.
- Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.
详细描述
- Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues.
The patients will be randomly divided into 2 groups:
- Experimental group: Reciproc reciprocating instrumentation system.
- Control group: One Shape rotary instrumentation system.
- Sequence of Procedural steps
- Preoperative pain will be assessed by Numerical Rating Scale (NRS) before administration of anesthesia.
- Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline).
- An access cavity will be performed using round bur and Endo-Z bur.
- The tooth will be properly isolated with rubber dam.
- Working length will be determined using an electronic apex locator, and working length will be confirmed by radiograph using K-file. Then the working length will be established at 0.5 mm up to the radiographic apex.
- Canals will be explored with hand K-file ISO sizes 10, 15, 20.
- Mechanical preparation for both groups will be as follows:
-
Experimental group:
-
Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
-
There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
-
Reciproc file selection: R40 (40/0.06) is to be used.
-
Control group:
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
- 25 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single-rooted mandibular premolar teeth with:
- •Preoperative sharp pain.
- •Vital response of pulp tissue.
- •Normal periapical radiographic appearance or slight widening in lamina dura.
排除标准
- •i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
- •ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
- •iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.
- •vi. Patients having bruxism or clenching. vii. Teeth that have:
- •Non vital pulp tissues.
- •Association with swelling or fistulous tract.
- •Pocket depth greater than 5 mm.
- •Previous endodontic treatment.
研究组 & 干预措施
Reciproc
- Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals.
- Size: R40 (40/0.06)
干预措施: Reciproc (Procedure)
One Shape
- One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals.
- Size: 25/0.06
干预措施: One Shape (Procedure)
结局指标
主要结局
postoperative pain
时间窗: Up to 72 hrs after treatment
Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)
次要结局
- Number of analgesic tablets taken after endodontic treatment(up to 72 hours after treatment)
研究者
Michel Karam Eissa Elias
Resident at endodontic department - Faculty of Oral and Dental Medicine- Cairo University
Cairo University
