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临床试验/NCT07046533
NCT07046533尚未招募不适用

Evaluation of the Success Rate of Full Coronal Pulpotomy as Compared to Conventional Root Canal Therapy in the Management of Mature First Permanent Molars With Irreversible Pulpitis in Children

Lamiaa Saeed Ahmed Elshiekh0 个研究点目标入组 60 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
success rate

研究概览

简要总结

The goal of This current study compare the clinical & radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.

详细描述

The teeth were anesthetized with 4% articaine with adrenaline 1/100,000 , isolated under rubber dam , and sterilized using a cotton pellet soaked in 2.5% sodium hypochlorite (NaOCl). Then carious leisons were removed by using a fresh sterile high-speed diamond bur under copious water irrigation. Upon pulp exposed, the cavity was rinsed with 2.5% NaOCl. The other steps of the treatment proceeded accordingly:

The procedure FP involved the removal of all coronal pulp tissue to the canals orifices level through a fresh sterile high-speed diamond bur Hemostasis was accomplished by compressing a cotton pellet soaked in 2.5% NaOCl over the radicular pulp tissue for 5 min. Then, irrigation with amount of sterile 0.9% sodium chloride (NaCl) solution was gently conducted. Once hemostasis was achieved, the radicular pulp tissue was observed as uniformly reddish pink color. Subsequently, a new type of premixed pulp-capping bio c repair ) was prepared according to the manufacturer's instructions, and a 4-mm layer was directly adapted over the radicular pulp tissue, ensuring that there was not any excess materials on the pulp chamber walls. The access cavity was restored with a liner)and composite restoration all completed in a single visit. Then postoperative radiographs were taken.

RCT was conducted in single visit the pulp tissues were removed from all the root canals, identifying and enlarging canal orifices via fanta Gold rotary , determing the working length with an apex locator. The root canals preparation was conducted by rotary nickel-titanium files, irrigated by using 2.5% NaOCl and 17% ethylenediaminetetraacetic acid (EDTA), and disinfected by using Ca(OH)2.

obturation was performed with gutta-percha and biocermaic sealer, using single cone technique.The access cavity was restored with a liner and resin composite restoration during the same appointment while using rubber dam isolation.

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
9 Months 至 14 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Molars teeth with a history of spontaneous radiating pain indicated IP
  • •the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.
  • •Molars teeth with no prominent radiolucency at the periapical or furcation regions

排除标准

  • •Teeth with continuous bleeding
  • •Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).
  • •Teeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification

研究组 & 干预措施

root canal treatment

Active Comparator

invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer

干预措施: (pulpotomy) (Procedure)

root canal treatment

Active Comparator

invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer

干预措施: root canal treatment (Procedure)

pulpotomy

Experimental

non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair

干预措施: (pulpotomy) (Procedure)

pulpotomy

Experimental

non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair

干预措施: root canal treatment (Procedure)

结局指标

主要结局

success rate

时间窗: 12 months

clinically and radiographically success rate according to success criteria

success rate

时间窗: 12 months

clinically and radiographically success rate according to success criteria

次要结局

未报告次要终点

研究者

发起方
Lamiaa Saeed Ahmed Elshiekh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lamiaa Saeed Ahmed Elshiekh

Assistant Lecturer of Pediatric Dentistry, Faculty of Dentistry October 6th University

Cairo University

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