Effect of Conservative Root Canal Preparation on Postoperative Pain: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
The goal of this clinical trial is to compare the pain experienced by healthy participants after root canal treatment with small versus large root canal sizes.
The main questions it aims to answer are:
- Do small and large root canal sizes cause different pain levels?
- What is the number of painkiller pills taken by each participant?
- Does small root canal size cause severe pain and facial swelling?
The researcher will perform root canal treatment on lower molar teeth. The researcher will ask about the pain level, painkiller pill number, and swelling on the 6th,12th, 24th, 48th, 72nd hours, and 7th day after the treatment.
详细描述
Root canal shaping is an essential step for root canal treatment. Necrotic tissues, debris, microorganisms, and organic matter should be removed to clean and disinfect the root canals. Previously, this conventional procedure involved removing excessive dentine from root canals, which weakened the tooth's structural integrity. Due to technological advances, excessive dentine removal is not always necessary. Root canals are claimed to be disinfected despite minimal dentine removal. This concept of treatment is called minimally invasive or conservative root canal treatment.
This study compares postoperative pain after conservative and conventional root canal preparation in healthy participants with necrotic mandibular molars.
Participants will be enrolled after clinical and radiographic examination by an independent endodontist and allocated randomly to conventional or conservative root canal treatment groups. After the root canal treatment, the researcher will send the participants an online questionnaire on the 6th,12th, 24th, 48th, and 72nd hours and 7th day and ask them to rate their pain score according to the Numerical Rating System and the number of painkillers they have taken. The flare-up rate will be determined according to the presence of swelling and severe pain.
An experienced endodontist not involved in the research will monitor eligible participants and clinical treatment protocol.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mandibular molar tooth
- •asymptomatic apical periodontitis
- •pulp necrosis
- •periapical lesion index 4 (visible and well-defined periapical lesion)
- •absence of pretreatment pain
排除标准
- •symptomatic apical periodontitis
- •preoperative pain
- •sinus tract
- •acute apical abscess
- •tooth not being in occlusion
- •external and internal root resorption
- •open apices
- •periodontal probing depth of more than 4 mm
- •initial apical file larger than 15 and 20 K-File for mesial and distal canals respectively
- •chronic illness, analgesic allergy, prior analgesic and antibiotics usage 12 hours and 3 months before treatment, respectively
结局指标
主要结局
Postoperative pain
时间窗: 7 days
Pain after root canal treatment will be assessed via the Numerical Rating System (NRS) at the 6th, 12th, 24th, 48th, and 72nd hours and on the 7th day. In the NRS, pain is evaluated by numbers from 0 to 10. A score of minimum means no pain, and a score of maximum 10 means the worst pain imaginable.
次要结局
- Analgesic intake(7 days)
- Flare-up(7 days.)
研究者
Cagla Vardar
Principal Investigator
Istanbul University