Effect of Different Root Canal Instruments on Removal of Endotoxins From Necrotic Root Canals (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- endotoxin change
研究概览
简要总结
• Grouping: The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext
- Endodontics procedure steps:
- Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
- All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.
2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.
2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator.
3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.
4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone).
5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique.
Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
详细描述
Materials and Methods:
A. Trial Design:
The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT). The clinical trial involves research using human participants. In this trial, the participants will be randomly allocated to receive one of two interventions according to the protocol created by the investigator; one of these interventions will be the control. The investigator is to determine the safety and/or the efficacy of the interventions after being received by the participants by measuring the outcomes because the outcomes will be measured, RCTs are quantitative studies.
• Grouping: The patients will be randomly assigned into two equal groups according to the type of rotary endodontic system used during root canal preparation: Group : OneShape Group : ProtaperNext
- Endodontics procedure steps:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are medically free and good health.
- •Patient 's age between 20-60years.
- •Patients with posterior teeth diagnosed clinically and confirmed by thermal sensitivity tests as teeth with necrotic pulp.
- •Positive patient's acceptance for participation in the study.
排除标准
- •-Pregnancy or lactation
- •Medically compromised patients -Patients aged less than20 or more than 60 years.-
- •Patients unable to give informed consent.
- •Previous endodontic therapy of the affected tooth .
- •Teeth diagnosed with vital pulp.
- •Teeth with periodontal pocket more than 3mm deep.
- •Teeth with abnormal anatomy and calcified canals.
- •Teeth with caries below the bony level (non-restorable tooth).
- •Teeth with periapical swelling or sinus tract.
研究组 & 干预措施
one shape
single file rotary system
干预措施: one shape (Other)
protaper next
multiple file rotary system
干预措施: protaper next (Other)
结局指标
主要结局
endotoxin change
时间窗: Samples will be collected before and after chemomechanical preparation over 2 months
Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
次要结局
未报告次要终点
研究者
Heba Elasfouri
lecturer of endodontics- faculty of dentistry- cairo university
Cairo University