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临床试验/CTRI/2024/12/078499
CTRI/2024/12/078499已完成不适用

Efficacy of Pulpotec in Preserving Hopeless Necrotic Primary Teeth: A Prospective Clinical and Radiographic Study

GITAM Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Clinical examination: The tooth should be devoid of pain, swelling, tender on percussion, mobility or fistula

研究概览

简要总结

Maintaining primary teeth as natural space maintainers until their natural exfoliation is essential for proper dental development. For non-vital primary molars with poor prognosis, a new treatment approach is needed to avoid extraction in order to reduce apprehension in young children.This preliminary study aims to evaluate the initial clinical and radiographic success of Pulpotec for non instrumental endodontic therapy(NIET) for treating non-vital primary teeth indicated for extraction.The study includes non-vital primary molars in children aged 4 to 8 years. The molars were treated using NIET with PULPOTEC. The procedure will be completed in a single visit. Follow-up evaluations were conducted clinically and radiographically at 3 months and 6 months. Data obtained will be statistically analysed.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Healthy children The pulp is judged as necrotic or partially necrotic.
  • Tooth with poor periodontal support (mobile) presence of sinus tract or swelling.
  • Presence of internal or pathologic external root resorption, calcification or pulp canal obliteration.
  • Prominent radiolucency at the furcation or periapical regions.
  • Restorable tooth.

排除标准

  • Unrestorable teeth Children with debilitating diseases.

结局指标

主要结局

Clinical examination: The tooth should be devoid of pain, swelling, tender on percussion, mobility or fistula

时间窗: Baseline, 3 months and 6 months

次要结局

  • Radiographic outcome:(Reduction in periapical pathology)

研究者

发起方
GITAM Dental College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jayalakshmi Pandranki

GITAM Dental College and Hospital

研究点 (1)

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