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临床试验/NCT06488131
NCT06488131尚未招募4 期

A Comparative Study Between MTA Pulpotomy and Root Canal Treatment in Management of First Permanent Molars With Irreversible Pulpitis in Children: A Randomized Controlled Trial

Ain Shams University0 个研究点目标入组 62 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
62
主要终点
Pain Relief

研究概览

简要总结

Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.

The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.

详细描述

In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.

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)

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy male and female children, aged 10 to 14 years
  • •Signs and symptoms of irreversible pulpitis in carious first permanent molar.

排除标准

  • •Molars with immature roots
  • •Non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm)
  • •Any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening.
  • •Any signs of periapical or furcal rarefaction.

研究组 & 干预措施

Root Canal Treatment

Active Comparator

Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Length of the root canal will be obtained using an apex locator. This will be followed by mechanical shaping using files, and irrigation with 2.5 percent sodium hypochlorite, followed by drying of the canals using paper points. Obturation will then be accomplished using gutta percha and sealer. Finally, the tooth will be restored with conventional glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week.

干预措施: Root Canal Treatment (Procedure)

MTA Pulpotomy

Experimental

Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Coronal pulp tissue will be removed to the level of canal orifices using a sterile, sharp spoon excavator. A cotton pellet dampened with sodium hypochlorite will be applied on canal orifices to achieve hemostasis. This will be followed by MTA application and glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week.

干预措施: MTA Pulpotomy (Procedure)

结局指标

主要结局

Pain Relief

时间窗: preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.

A 10 cm visual analogue scale will be used to record pain

次要结局

  • Radiographic Evaluation(6, 12 and 18 months postoperatively)
  • Clinical Evaluation(3, 6, 12 and 18 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Eissa

Assistant Lecturer

Ain Shams University

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