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临床试验/NCT05747300
NCT05747300尚未招募不适用

Clinical and Radiographic Evaluation of Premixed Bioceramic Paste (Wellroot PT) Versus Mineral Trioxide Aggregate (MTA) in Pulpotomy of Primary Molars: A Randomized Clinical Pilot Study

Cairo University0 个研究点目标入组 24 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
Pain to percussion

研究概览

简要总结

compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in primary molars.

详细描述

Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry .

One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependant and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.

Premixed bioceramics Well-Root™ PT (Vericom, Gangwon-Do, Korea) have been introduced into the market and present with desirable properties as a pulp capping agent. Owing to good handling characteristics, biocompatibility, odontogenic property and antibacterial action, the premixed bioceramic materials are recommended for procedures such as pulp capping, pulpotomy, perforation repair, root-end filling, and obturation.

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

入选标准

  • • Children aged between 4 years and 7 years.
  • Mandibular second primary molar with deep caries involving pulp.
  • No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
  • Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
  • Radiographic criteria:
  • No sign of radiolucency in periapical or furcation area.
  • No widening of PDL space or loss of lamina dura continuity.
  • No evidence of internal/external pathologic root resorption.

排除标准

  • • Uncooperative children.
  • Children with systemic disease.
  • Lack of informed consent by the child patient's parent.
  • Unable to attend follow-up visits.
  • Refusal of participation.

结局指标

主要结局

Pain to percussion

时间窗: 1 year

Binary (present/absent) Percussion test by the back of the dental mirror

Soft tissue pathology

时间窗: 1 year

Binary (present/absent) Visual clinical examination

Pathologic mobility

时间窗: 1 year

Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)

Post-operative pain

时间窗: 1 year

Binary (present/absent) Verbal question to patient/ parent

次要结局

  • Absence of furcation or periapical radiolucency Absence of external or internal root resorption(1 year)

研究者

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

Doaa Gamal

Doaa Gamal Mohamed

Cairo University

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