跳至主要内容
临床试验/NCT07522723
NCT07522723尚未招募不适用

Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate Used As Pulpotomy Agents In Vital Immature Permanent Molars With Irreversible Pulpits. A Randomized Control Trial

Cairo University0 个研究点目标入组 60 人开始时间: 2026年4月20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
入组人数
60
主要终点
Radiographic examination of complete apical closure

研究概览

简要总结

The aim of this study is to assess Clinical and Radiographical effect of Bio C repair, Biodentine and Mineral Trioxide Aggregate when used as pulpotomy Agents in Immature Permanent Molars with Pulpits.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Children aged 6-10 years with asymptomatic/symptomatic disease and having vital immature permanent posterior teeth with clinical exposure to dental caries of the pulp and bleeding.
  • Posterior teeth had deep caries with pulp exposure.
  • Posterior teeth that exhibited preoperative symptoms, such as referred pain, spontaneous pain or pain induced during thermal and cold sensitivity tests, with a range of symptoms that can last from seconds to hours compared to the control teeth.
  • Posterior teeth without prominent radiolucency in the furcation or periapical regions.
  • The posterior teeth could be restored.
  • Children with prior parental consent.

排除标准

  • • (1) Patients with contraindications of the to-be-performed dental treatment.
  • (2) Teeth with completed VPT or RCT.
  • (3) Teeth with furcation, prominent radiolucency in the periapical regions, or external or internal resorption.
  • (4) Teeth with pulpitis attributed to tooth fracture, cracking, periodontitis or wedge-shaped defects.
  • (5) Teeth without any response to experiments of vitality. (
  • 6) Teeth with formed root/closed apex.
  • (7) Teeth with edema, fistula and excessive mobility not associated with periodontal disease.

研究组 & 干预措施

Biodentine

Experimental

Pulpotomy using Biodentine in carious Immature permanent molars with irreversible pulpitis.

干预措施: Biodentine (Other)

MTA

Active Comparator

Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis.

干预措施: Biodentine (Other)

Bio C repair

Experimental

Pulpotomy using Bio C repair in carious Immature permanent molars with irreversible pulpitis.

干预措施: Bio C repair (Other)

MTA

Active Comparator

Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis.

干预措施: Bio C repair (Other)

结局指标

主要结局

Radiographic examination of complete apical closure

时间窗: 12 months

Digital Radiographic examination using visual examination of the teeth were made using the TPC paralleling device

次要结局

  • The presence of Sinus or fistula(12 months)
  • tenderness associated with the tooth.(12 months)
  • Presence of pain(12 months)
  • The presence of Swelling(12 months)

研究者

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

Alaa Yasser ElSheikh

PhD candidate

Cairo University

相似试验