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临床试验/NCT05665803
NCT05665803尚未招募不适用

Comparative Evaluation of Instrumentation Time, Obturation Quality, and Child's Behavior Using Pediatric Rotary Versus Hand (Flare) File Systems in Treatment of Primary Molars: a Split Mouth Randomized Clinical Trial

Cairo University0 个研究点目标入组 23 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
23
主要终点
Instrumentation time

研究概览

简要总结

The study will be conducted to evaluate instrumentation time, obturation quality, and child's behavior using pediatric rotary versus hand flare file systems in treatment of primary molars.

详细描述

Statement of the problem:

Pulpally affected primary teeth is a common problem in children due to lower mineralization, the presence of large pulp chamber with high pulp horns, and thin layers of enamel and dentin .

Manual files system is usually used for management of pulpally affected primary molars. This system has shown through the past years an acceptable clinical success rate but it also have many problems such as long visit time affecting the child behavior and causing fatigue to the dentist, difficulty in dealing with thin and curved canals due to limited flexibility of manual files causing incomplete removal of pulp tissue, and also difficulty in the determination of the actual working length due to the presence of physiologic and pathologic root resorption.

Rationale for conducting the research:

Pulp therapy in primary molars becomes compromised sometimes after delayed treatment due to dental neglect of children till caries progression to the pulp leading to severe symptoms associated with excessive pulp inflammation, root resorption, or periradicular bone resorption with a less favorable prognosis for conventional endodontic therapy. In the current era, a new perspective which is less time consuming with an acceptable success rate could be a spark of hope for the pediatric patient as well as the dentists.

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 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cooperative children.
  • 4-6 years old children.
  • Children who will attend follow up.
  • Bilateral lower second primary molars.
  • Pulpally involved molars indicated for pulpectomy.

排除标准

  • Children with physical or emotional alteration.
  • Children with systemic diseases.
  • Children of parents who don't accept to participate in the study.
  • Teeth with more than 1/3 of root resorption.
  • Teeth with pathological mobility.
  • Necrotic teeth with periapical or furcal lesions.
  • Non restorable teeth.

结局指标

主要结局

Instrumentation time

时间窗: during procedure

Continuous outcome measured by digital stopwatch in minutes

次要结局

  • Pain on biting(1 year)
  • Swelling/ fistula / sinus tract(1 year)
  • Furcation involvement or periapical radiolucency(1 year)
  • Tenderness to percussion(1 year)
  • Child's behaviour(during procedure)
  • Postoperative pain(7 days)
  • Mobility(1 year)
  • Internal or external root resorption(1 year)

研究者

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

Ahmed Wafik Ismael Mohamed

Assistant lecturer, department of pediatric dentistry

Cairo University

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