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临床试验/NCT04650113
NCT04650113Unknown1 期

Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
1 期
入组人数
1
试验地点
2
主要终点
swelling

研究概览

简要总结

that's comparison between partial and complete pulpotomy techniques in primary teeth

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All participants will be randomly assigned to know which one of the right or left side will be allocated randomly in either the control or the intervention group.

Sequence Generation Eligible consented participants will be randomly assigned to know which one of the participants will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized. The table of sequence generation will be kept with the co-supervisor.

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medically free children who will be able and cooperative in all steps of the study.
  • Asymptomatic primary molars with a deep carious lesion.
  • Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
  • 3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
  • 4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.

排除标准

  • 1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
  • 6 - Parent or guardians who refuse participating in the study

结局指标

主要结局

swelling

时间窗: 6 months

clinical examination

postoperative pain

时间窗: 6 months

analog scale

mobility

时间窗: 6 months

clinical examination

次要结局

  • root resorption(6 months)
  • Bone resorption(6 months)

研究者

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

fatma zainalabdieen abdelraouf

Master degree student

Cairo University

研究点 (2)

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