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临床试验/CTRI/2026/04/108076
CTRI/2026/04/108076尚未招募4 期

Radiographic Evaluation of Obturation Quality in Mandibular Second Primary Molar Using Kedo Z-Plus, Metapex and Endoflas- An In-Vivo Randomized Controlled Trial

Somya Seth1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This randomized controlled clinical trial aims to compare the radiographic quality of root canal obturation in mandibular second primary molars using three different obturating materials in children aged 4 to 7years. Eligible children requiring pulpectomy will be randomly allocated into three groups. Each group will receive root canal obturation with one of the study materials following standardized clinical procedures. The primary outcome will be the radiographic assessment of obturation quality immediately after treatment. The findings of this study are expected to provide evidence on the relative effectiveness of different obturating materials in pediatric endodontic treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • 1.Children aged 4 to 7 years.
  • 2.Children requiring pulpectomy in at least one mandibular second primary molar.
  • 3.Teeth diagnosed with irreversible pulpitis or necrotic pulp, indicated for pulpectomy.
  • 4.Mandibular second primary molars with at least two-thirds of root length remaining and without advanced physiologic root resorption.
  • 5.Teeth with restorable crowns and adequate remaining tooth structure.
  • 6.Children with no known systemic diseases affecting healing or dental treatment.
  • 7.Children whose parents/guardians provide written informed consent.

排除标准

  • 1.Children younger than 4 years or older than 7 years.
  • 2.Mandibular second primary molars with advanced physiologic or pathologic root resorption (more than one-third of root length).
  • 3.Teeth with internal or external pathological resorption.
  • 4.Teeth with non-restorable crowns, vertical root fractures, or extensive structural damage.
  • 5.Teeth with periapical pathology involving the permanent successor tooth germ.
  • 6.Teeth with severe root canal calcification, obliteration, or abnormal morphology preventing proper instrumentation.
  • 7.Children with systemic illnesses, immunocompromised status, or conditions affecting wound healing.
  • 8.Children with known allergy or hypersensitivity to any components of the obturating materials.
  • 9.Children who are uncooperative or unable to tolerate treatment under routine clinical conditions.

研究者

发起方
Somya Seth
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Somya Seth

Saveetha Dental College and Hospitals

研究点 (1)

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