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临床试验/NCT06158451
NCT06158451尚未招募不适用

Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in Lesion Sterilization and Tissue Repair (LSTR) for the Treatment of Necrotic Primary Molars: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2024年3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
40
主要终点
Tenderness to percussion

研究概览

简要总结

The aim of this study is to evaluate and compare the clinical effectiveness of zinc oxide-propolis mixture with triple antibiotic paste in LSTR as root canal filling material in necrotic primary molars.

详细描述

The promising results of propolis as a natural antibiotic in previous in- vivo studies made it interesting to combine propolis to the golden standard zinc oxide eugenol as an intracanal medication in pulp affected primary molars and use this mix as a natural substitute to the modified triple antibiotic paste (m-TAP) and therefore overcoming the antibiotic bacterial resistance, allergy and developmental anomalies that might arise in permanent successor teeth from m-TAP usage.

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

Double

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children:
  • Cooperative children aged 4 -7 years old.
  • Systemically healthy.
  • Clinical criteria:
  • Necrotic primary mandibular second molar teeth.
  • Spontaneous pain or tenderness to percussion
  • Deep carious lesion with pulp exposure.
  • Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)
  • Radiographic criteria:
  • Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
  • Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)

排除标准

  • Children:
  • With physical or emotional alteration.
  • Children with systemic disease.
  • Previous history of allergy to antibiotics used in the study.
  • Children that will not attend follow up. • Teeth:
  • Non restorable carious primary molars.
  • Grade III mobility

结局指标

主要结局

Tenderness to percussion

时间窗: 1 year

(binary outcome measured by percussion test using back of the dental mirror

Postoperative pain

时间窗: 1 year

Binary outcome measured with direct questioning to the patient

Swelling / sinus tract

时间窗: 1 year

binary outcome measured with visual examination of the patient examination of the patient

Mobility

时间窗: 1 year

(measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success

次要结局

  • Radiographic success(6 months)

研究者

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

Sara Khaled Adam

Assistant lecturer pediatric dentistry

Cairo University

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