The Impact of Using Different Final Irrigation Modes on Postoperative Pain Following Root Canal Treatment of Non-vital Mandibular First Molar With Periapical Lesion. "Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn which rinsing of root canals method works best to lower pain after a root canal in adults. The study focuses on participants aged 20 to 40 with an infection in a lower back tooth (mandibular first molar) and a small area of bone loss at the root tip.
The main questions it aims to answer are:
Does the type of tool used to rinse the tooth root canal change how much pain a participant feels after treatment?
Does the cleaning method lower the number of painkillers a participant needs to take?
Researchers will compare four different rinsing tools-ranging from a standard needle to advanced vacuum and vibration devices-to see if using suction and sound waves can lower pain levels.
Participants will:
Receive a complete root canal treatment in a single visit
Be randomly assigned to one of four cleaning groups (standard rinse, vibration, vacuum, or a combination of both)
Rate their pain on a scale of 0 to 10 at five specific times: before the visit, and at 6, 12, 24, and 48 hours after treatment
Record how many painkiller tablets (Ibuprofen) they take during the two days following the procedure
详细描述
Clinical Study Protocol
- General Information Study Title: The impact of using different final irrigation modes on postoperative pain following root canal treatment of mandibular first molar with symptomatic periapical lesions: A Randomized Controlled Trial.
Protocol Date: May 2026
Sponsor/Institution: Department of Endodontics, Faculty of Oral and Dental Medicine, Future University in Egypt.
Principal Investigator: Osama Said Abdrabou Mohamed, BDS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
the first blinding will be to the participants, where they will not know the type of irrigation activation device used the second blinding will be to the investigator, where another individual will be assigned to follow up with the participants and record the outcome measures the third blinding will be to the outcome assessors, where they will be blinded to the groups
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower first molar Classification of root canal configuration according to weine classification: -
- •Distal root: any type of root canal configuration given that the portal of exit is through only one apical foramen
- •Mesial root: any type of root canal configuration given that the portal of exit is through only one apical foramen(18).
- •Patient with mild pre-operative pain with pain score from 0-3
- •Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- •The age range is between 20 to 40 years.
- •Patients have restorable lower permanent molars that were diagnosed with symptomatic apical periodontitis with small to moderate periapical lesion.
- •Positive patient's acceptance for participating in the study.
- •Patients able to sign informed consent.
排除标准
- •Patients with systemic conditions that may affect pain perception (e.g., fibromyalgia, chronic pain disorders)
- •Patients currently taking or taken analgesics or anti-inflammatory medications before the trial in the last 12 hours.
- •Pregnant or lactating females.
- •Psychologically disturbed patients.
- •Patients with a history of allergy to any medication used in the study are excluded.
- •Teeth that have:
- •Periodontally affected with grade 2 or 3 mobility.
- •Not restorable teeth.
- •Abnormal anatomy and calcified canals.
- •Previous root canal treatment.
- •Any patient that matched the inclusion criteria, however had an unintentional errors during procedure, eg: over-instrumentation/over-obturation.
研究者
Osama Said Abdrabou Mohamed
clinical instructor
Future University in Egypt