Impact of Minimally Invasive Endodontic Treatment on the Prognosis of Mandibular Permanent Molars With Necrotic Pulp and Apical Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
Statement of the problem: The effectiveness of minimally invasive endodontic treatments in managing necrotic pulp with apical periodontitis remains understudied. Aim of the study: This research aims to evaluate the outcomes of minimally invasive versus traditional root canal treatments in patients with necrotic pulp associated with apical periodontitis. Material and methods: sixty healthy patients of both genders aged from 20 to 50 years old suffering from necrotic pulp associated with apical periodontitis in their lower first molars with four root canals will be included in this study. The initial assessment will include a preoperative CBCT scan. Participants will be randomly assigned according to the type of endodontic treatment to two groups; a traditional treatment group (Trad); in which a traditional access cavity design and root canal preparation extending three sizes beyond the initial apical file using taper .04 rotary files will be accomplished and a minimally invasive group (MI) in which a conservative access cavity and a conservative root canal preparation up to #20/.04 will be performed. Both groups will receive an identical irrigation protocol during root canal instrumentation augmented with passive ultrasonic activation. Immediately following biomechanical preparation, the root canals will be filled with single cone obturation technique. Root canal disinfection will be evaluated using a culture method in which two bacterial samplings will be collected, one before and another after the biomechanical preparation. Patients will be monitored over 12 months, concluding with a follow-up CBCT scan to assess periapical healing. Data will be collected and statistically analyzed.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with free medical history (category: American Society of Anaesthesiologists class I) from either gender aged from 20 to 50 years old.
- •Necrotic lower first molars with four root canals (two mesials and two distals).
- •Teeth have a periapical radiolucency with a diameter of 2-4 mm in CBCT images.
- •Teeth show root curvature of 10°-20° as described by Schnider.
- •Participant that indicated for single visit root canal treatment.
排除标准
- •Calcified or non-negotiatable teeth.
- •Participants who cannot apply for the follow-up schedule.
- •Teeth that show any signs of cracks or vertical root fractures.
- •Teeth that show less than 50% of sound coronal tooth structure.
- •Periodontally affected teeth.
研究组 & 干预措施
Traditional group
In this group traditional access cavity and canal preparations is done
干预措施: Root canal treatment (Procedure)
Minimally invasive group
In this group conservative access cavity and minimally invasive root canal preparation is done
干预措施: Root canal treatment (Procedure)
结局指标
主要结局
Success rate
时间窗: 1 year follow up
A case is deemed successful if there is no clinical signs and symptoms of infection or inflammation and radiographic bone healing. The success rate for each group will be determined by the ratio of successful cases to the total number of cases in that group.
次要结局
- Healing of periapical lesion(1 year)
- Bacterial load(Within 2 days after intervention)
- Treatment duration(During procedure)
- Iatrogenic errors(During procedure)
研究者
Mohamed Ashraf Abdeen
Assistant lecturer in endodontics, ,faculty of dentistry, Assiut University
Assiut University
