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临床试验/NCT07488416
NCT07488416招募中不适用

Comparative Evaluation of Clinical and Radiographic Outcomes of Lesion Sterilization and Tissue Repair Using Zinc Oxide/ 6-gingerol Mix Versus Triple Antibiotic Paste in Non-vital Primary Molars: A Randomized Clinical Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Assessment of pain

研究概览

简要总结

This study aims to evaluate and compare the clinical and radiographic outcomes of Lesion sterilization and tissue repair using zinc oxide/ 6-gingerol mix versus triple antibiotic paste in non-vital primary molars.

详细描述

In routine dental practice, clinicians often face challenges when primary teeth are affected by dental caries and periapical changes, which may exceed the limits of conventional endodontic treatments. Extraction often becomes the only viable option due to factors like extensive root resorption, poor bone support, and uncooperative young patients.

One promising less invasive method is Lesion Sterilization and Tissue Repair (LSTR), developed by Niigata University. This approach uses minimal instrumentation and applies an antibiotic mixture to disinfect the root canal and periapical lesions, often using a "three mix MP paste" of metronidazole, ciprofloxacin, and minocycline. Recently, clindamycin has been used instead of minocycline to avoid tooth discoloration.

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
Single (Participant)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 4 to 8 years.
  • Both sexes
  • Children must have at least two restorable non-vital primary molars
  • Periapical radiolucency.
  • Pain on mastication.
  • Pathological mobility.
  • Internal or external root resorption.
  • Furcation involvement should not extend to the developing tooth germ.

排除标准

  • Presence of systemic diseases.
  • Teeth with physiological mobility near exfoliation time.
  • Teeth with vital pulp.

结局指标

主要结局

Assessment of pain

时间窗: 6 months postoperatively

Pain will be assessed using age-appropriate pain scales (5-point Likert scale for children) with 0 typically representing "no pain" and 4 representing "very high/extreme pain".

次要结局

  • Tooth mobility(One year postoperatively)

研究者

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

Ahmed El-Sayed El-Metwally

B.D.S, Faculty of Dentistry (Cairo-Boys), Al-Azhar University, Cairo, Egypt.

Al-Azhar University

研究点 (1)

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