Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT. A 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
- 主要终点
- healing of periapical lesion
研究概览
简要总结
The goal of this clinical trial is to learn how different ways of activating the cleaning liquid (irrigation) during endodontic treatment affect healing of infections at the root tip (periapical lesions) in adults aged 20 to 40 with a lower first molar tooth.
The main question it aims to answer is:
Does the way the cleaning liquid is moved inside the tooth during endodontic treatment change how well the infection at the root tip heals after 12 months?
Researchers will compare four irrigation methods to see which one helps the infection heal best:
A regular needle and syringe (the standard endodontic method) Ultra X, which uses sound waves to push the liquid through the tooth Endo Vac, which uses gentle suction to pull the liquid through the tooth I Vac, which combines suction and sound waves
Participants will:
Have their endodontic treatment done in one visit by the same dentist Be randomly placed into one of the four groups Return for check-ups at 3, 6, and 9 months after endodontic treatment Come back at 12 months for a final check-up and a 3D dental scan (CBCT) to measure how much the infection has healed
详细描述
Periapical lesions are areas of infection and inflammation at the tip of a tooth's root. They develop when bacteria from inside the tooth's root canal system spread to the surrounding bone. Endodontic treatment (root canal treatment) aims to remove these bacteria so the infection can heal.
A key part of endodontic treatment is irrigation, which means rinsing the inside of the tooth with cleaning liquids to wash out bacteria, infected tissue, and debris. The two main cleaning liquids used in this study are sodium hypochlorite (NaOCl), which dissolves infected tissue and kills bacteria, and EDTA, which removes the smear layer (a thin film of debris left on the canal walls after cleaning).
The standard way to deliver these liquids is with a needle and syringe. However, the inside of a tooth has complex shapes, narrow areas, and side branches that a needle may not reach. To improve cleaning, dentists can use special devices that activate the liquid, helping it flow into these hard-to-reach areas. Different activation methods work in different ways:
Positive pressure activation uses sound waves to push the liquid deeper into the canals Negative pressure activation uses gentle suction to pull the liquid through the canals toward the root tip, which also helps stop the liquid from being pushed out beyond the root Combined activation uses both suction and sound waves at the same time
It is not yet clear which activation method leads to the best healing of periapical lesions over time. This study will compare four irrigation methods in adults to find out.
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)
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
- •- 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 Mandibular permanent molars that were diagnosed with necrotic pulp with symptomatic apical periodontitis (with small to moderate periapical lesion/≤ 5mm) .
- •Positive patient's acceptance for participating in the study.
- •Patients able to sign informed consent.
- •Both male and female patients are eligible.
- •Good oral hygiene.
- •Mandibular first molars with two roots (mesial and distal), each presenting a Weine Type III canal configuration.
排除标准
- •- Medically compromised patients.
- •Pregnant or lactating females.
- •Psychologically disturbed patients.
- •Patients with a history of allergy to any medication used in the study were excluded.
- •Mandibular first molar with:
- •Wide or open apex.
- •Vital pulp tissues.
- •Periodontally affected with grade 2 or 3 mobility.
- •Not restorable teeth.
- •Abnormal anatomy and calcified canals.
- •Previous root canal treatment.
研究组 & 干预措施
side vented needle
single visit root canal treatment with final irrigation protocol using side vented needle
干预措施: root canal treatment (Procedure)
passive ultrasonic irrigation activation (Ultra X )
single visit root canal treatment with final irrigation protocol using ultrasonic ( Ultra X )
干预措施: root canal treatment (Procedure)
apical negative pressure irrigation activation ( Endo Vac)
single visit root canal treatment with final irrigation protocol using apical negative pressure irrigation activation( Endo Vac )
干预措施: root canal treatment (Procedure)
Apical Negative Pressure Irrigation and Activation System (iVac)
single visit root canal treatment with final irrigation protocol using Apical Negative Pressure Irrigation and Activation System (iVac)
干预措施: root canal treatment (Procedure)
结局指标
主要结局
healing of periapical lesion
时间窗: 12 month
percent reduction lesion size after root canal treatment using CBCT-PAI scores
次要结局
未报告次要终点
研究者
Mohamed Fawzy Mohamed Sayed Ahmed Omara
clinical instructor
Future University in Egypt