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临床试验/NCT06219824
NCT06219824尚未招募3 期

Clinical and Radiographic Evaluation of Bioceramic Putty Mineral Trioxide Aggregate Versus Mineral Trioxide Aggregate in Pulpotomy of Immature Permanent Molars: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 40 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
3 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars

The main question it aims to answer is:

Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?

详细描述

limited clinical trials have reported the clinical and radiographic outcomes after pulpotomy with premixed putty bioceramic MTA and conventional MTA in young permanent molars.

MTA has various drawbacks, such as difficulty in handling, long setting time, discoloration of the tooth, and its form as a powder/liquid which raise the responsibility for major material waste. To conquer these issues, bioceramic materials have been developed premixed putty bioceramic MTA is a ready-to-use material for immediate placement with zero waste, saving cost and chair time. Thus, the present study aims to evaluate bioceramic putty MTA's clinical and radiographic success versus MTA in pulpotomy of immature permanent molars.

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
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 6-8 years of both sexes have immature permanent molars
  • with deep carious lesions indicated for pulpotomy.
  • Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
  • Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
  • Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
  • permanent molars without internal and external root resorption, or calcification in pulp tissue.

排除标准

  • Medically compromised patients who have systemic disease.
  • Uncooperative patients who refuse treatment.
  • Permanent molars that were previously restored.

研究组 & 干预措施

control Group

Active Comparator

pulpotomy treatment for the young permanent teeth will be done using conventional powder and liquid Mineral Trioxide Aggregate followed by Glassionomer restoration and stainless steel crown

干预措施: Conventional MTA (Drug)

Experimental

Experimental

pulpotomy treatment for the young permanent teeth will be done using premixed ready for use bioceramic MTA followed by Glassionomer restoration and stainless steel crown

干预措施: premixed Bio-ceramic MTA (Drug)

结局指标

主要结局

Primary Outcome

时间窗: 24hrs, 1 week

Immediate Postoperative pain \[ Time Frame: one week) post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.

次要结局

  • Secondary outcome(6,12 month)

研究者

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

Marwa Abd El-Naby Hussien

Assistant lecturer of Pediatric Dentistry, Faculty of Dentistry, October University for Modern Sciences and Arts

Cairo University

研究点 (1)

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