Assessment of Postoperative Pain After Using Reciroc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis (A Randomized Clinical Trial): Part Two
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 主要终点
- Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
研究概览
简要总结
A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.
详细描述
The study aims at comparing postoperative pain after using two single-file NiTi systems, Reciproc reciprocating system and One Shape rotary system, for root canal instrumentation in patients with symptomatic irreversible pulpitis.
After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit.
Sequence of Procedural Steps:
- Assessment of preoperative pain by NRS before administration of anesthesia.
- Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline).
- An access cavity will be done using a round bur and Endo-Z bur.
- Isolation of the affected tooth with rubber dam.
- Determination of the working length using an electronic apex locator, and confirmed by a 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:
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
- 否
入选标准
- •Mandibular premolar teeth with:
- •Single canal
- •Preoperative sharp pain.
- •Vital response of pulp tissue.
- •Normal periapical radiographic appearance or slight widening in lamina dura.
- •Final diagnosis for an eligible patient will take place by radiograph and pulp testing.
排除标准
- •Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
- •Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
- •Pregnant females.
- •Patients having significant systemic disorder.
- •If antibiotics have been administrated during the past two weeks preoperatively.
- •Patients having bruxism or clenching.
- •Teeth that have:
- •Non-vital pulp tissues.
- •Association with swelling or fistulous tract.
- •A pocket depth greater than 5 mm.
- •Previous endodontic treatment.
结局指标
主要结局
Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
时间窗: Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.
Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)
次要结局
- Number of analgesics taken by the patient(72 hours from the end of the endodontic treatment)
研究者
Ahmed Adel Abdullah Ali Soliman
Masters Candidate
Cairo University