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临床试验/NCT07265089
NCT07265089尚未招募不适用

Clinical and Radiographic Evaluation of Success Rate of Zinc Oxide-Ozonated Olive Oil Versus Metapex as Root Canal Filling Materials in Primary Anterior Teeth: Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Clinical success: absence of pain, swelling, tenderness, or mobility

研究概览

简要总结

This randomized clinical trial compares zinc oxide-ozonated olive oil and Metapex as root canal filling materials in primary anterior teeth of children aged 3-5 years.

The study aims to evaluate their clinical and radiographic success over 12 months.Clinical evaluation includes pain, swelling, and mobility; radiographic evaluation includes periapical healing and resorption.

详细描述

Dental caries in primary anterior teeth significantly compromises aesthetics and function, particularly affecting children's psychosocial well-being and oral development. Esthetically, carious lesions in these visible teeth can lead to social avoidance, reduced self-esteem, and bullying risks, as children may avoid smiling or participating in activities. Pulpectomy of primary teeth is a critical to maintain arch integrity, function, and aesthetics in the pediatric population. Zinc oxide eugenol (ZOE) has been the most commonly used filling material in pulptherapy of primary teeth, achieving moderate to high success rates exceeding 90%. However, the slow resorption rate, which may not match the physiological root resorption of primary teeth, potentially leading to delayed natural exfoliation and complications with the eruption of permanent successors. it can also induce necrosis and delayed healing.

(ZOE) can cause irritation and sensitivity when in contact with oral tissues, primarily due to the eugenol component. Eugenol is recognized as a sensitizer and can induce both localized irritation and hypersensitivity reactions, including contact dermatitis, contact stomatitis, and, in rare cases, immediate allergic responses such as urticaria and generalized itching shortly after application.

Olive oil is a vegetal oil it contains antioxidants that enhance properties which can potentially overcome the limited antimicrobial activity of traditional ZOE. Ozonated olive oil has demonstrated excellent biocompatibility with surrounding tissues. This reduces the adverse reactions or irritation, making it a safer alternative for pediatric patients. Zinc oxide-ozonated olive oil may reduce the chances of overfilling and subsequent eruption complications. Promotes tissue repair and healing due to its anti-inflammatory and regenerative properties. This can contribute to quicker recovery and better clinical outcomes.

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)

盲法说明

Statistician

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-5 years.
  • Primary anterior teeth requiring root canal treatment due to irreversible pulpitis.
  • Cooperative behavior child.
  • Parents provided written informed consent. -

排除标准

  • Medically compromised children.
  • Tooth with advanced root resorption.
  • Non-restorable crown structures.
  • Tooth with abscess or fistula.
  • Allergies or hypersensitivity to any of the materials used e.g., zinc oxide, olive oil, or calcium hydroxide and Idoform (components of Metapex).
  • Unable to attend follow-up visits.

结局指标

主要结局

Clinical success: absence of pain, swelling, tenderness, or mobility

时间窗: 12 month intervals T0: 0 T1: 3month T2: 6month T3: 9month T4: 12month

次要结局

  • Radiographic success: absence of periapical radiolucency or root resorption(12 month intervals T0:0 T2: 6 month T4: 12month)

研究者

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

Raheeq Babiker Ibrahim Babiker

Principal Investigator

Cairo University

研究点 (1)

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