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临床试验/NCT06679075
NCT06679075已完成不适用

Clinical and Radiographic Evaluation of Propolis as a Hemostatic Agent in Full Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis Using Two Different Dressing Materials: A Randomized Clinical Trial

Misr International University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11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
已完成
入组人数
60
试验地点
1
主要终点
Clinical and radiographic success rate

研究概览

简要总结

The goal of this randomized clinical trial is to assess the effectiveness of propolis as a hemostatic agent in full pulpotomy for mature permanent molars with irreversible pulpitis, compared to sodium hypochlorite (NaOCl). The study also compares how bioceramic putty performs compared to mineral trioxide aggregate (MTA) as pulpotomy dressing materials.

Participants will be randomly allocated into four groups (15 patients each) according to the hemostatic agent and dressing material used:

  • Propolis + bioceramic putty
  • Propolis + MTA
  • Sodium hypochlorite + bioceramic putty
  • Sodium hypochlorite + MTA Bleeding time and postoperative pain will be recorded. Clinical and radiographic success will be evaluated at 1, 3, and 6 months following 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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants of both genders falling within the age range of 20 to 45 years.
  • •Presence of vital mature permanent molars diagnosed as irreversible pulpitis.
  • •Confirmation of vital bleeding pulp tissue in all canals following complete pulpotomy.

排除标准

  • •Non-vital teeth.
  • •Teeth with Immature roots.
  • •Uncontrolled pulpal bleeding persisting beyond 10 minutes post-application of sodium hypochlorite as a hemostatic agent.
  • •Insufficient bleeding post-pulp exposure, indicative of pulp degeneration.

研究组 & 干预措施

Propolis + Bioceramic putty

Experimental

Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and bioceramic putty as a dressing material.

干预措施: Full pulpotomy using propolis and bioceramic putty (Procedure)

Propolis + MTA

Experimental

Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using propolis as a hemostatic agent and MTA as a dressing material.

干预措施: Full pulpotomy using Propolis and MTA (Procedure)

Sodium hypochlorite + bioceramic putty

Experimental

Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and bioceramic putty as a dressing material.

干预措施: Full pulpotomy using sodium hypochlorite and bioceramic putty (Procedure)

Sodium hypochlorite + MTA

Active Comparator

Adult permanent molars diagnosed with irreversible pulpitis to be treated with full pulpotomy using sodium hypochlorite (NaOCl) as a hemostatic agent and MTA as a dressing material

干预措施: Full pulpotomy using sodium hypochlorite and MTA (Procedure)

结局指标

主要结局

Clinical and radiographic success rate

时间窗: 1, 3, 6 months

Success rate of full pulpotomy procedure using different hemostatic agents and different dressing materials using the clinical and radiographic criteria for success and failure.

Bleeding time

时间窗: During hemostasis (0-10 minutes)

Recording the bleeding time of different participants during hemostasis.

次要结局

  • Post-operative pain(24 hours, 3 days, 1 week)

研究者

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

Omar Hisham Selim

Master's Candidate in Endodontics

Misr International University

研究点 (1)

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