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临床试验/NCT04678141
NCT04678141已完成不适用

Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results

Suleyman Demirel University2 个研究点 分布在 2 个国家目标入组 145 人开始时间: 2018年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
2
主要终点
USPHS criteria

研究概览

简要总结

It was aimed to evaluate the clinical performance of resin-hybrid composite and compomer materials in primary molars over a 2-year period.

详细描述

All treatment stages were performed by the same experienced pediatric dentist (E.O.) to avoid behavioral problems. When necessary, topical anesthesia with 2% Xylocaine® DENTAL was administered, followed by local anesthesia with epinephrine 1: 100.000 (lidocaine HCl and Epinephrine Injection, DENTSPLY Pharmaceutical, USA). Access to proximal surfaces was provided with high-speed diamond bur (FD.D.801, Frank Dental, Germany) under an air-water coolant. The proximal cavity was opened at the occlusal level. Soft carious dentine was removed with a round low-speed steel bur (SS.1A, Frank Dental, Germany).

Restorations were placed under isolation with cotton rolls and a saliva ejector. The Ca(OH)2 cavity liner material (Hydrocal LC, Medicept Dental, India) was used as base material if the distance from the pulp was not safe. A metal matrix band (Matrix band, Hahnenkratt, Königsbach-Stein, Germany) was applied to the tooth with a universal matrix system (Tofflemire, Hahnenkratt, Königsbach-Stein, Germany) and wooden wedges (TDV, No 1). ClearfilTM SE Bond (Kuraray Medical Inc, Okayama, Japan) was applied to the cavity according to the manufacturer's instructions. For the polymerization, an LED curing light (Eliapar Freelight, 3M ESPE Dental Products, America) was used with a light power density of 600 mW/cm2. According to the manufacturer's instructions, A2 composite resin (Kerr Herculite Classic) and two different compomer materials (Dyract/XP and R&D Series NOVA) were applied to the teeth with the incremental technique, and each increment was light-polymerized for 20 sec with an LED curing light.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • * Mentally and physically healthy

排除标准

  • * Systemic disease or medical complications

结局指标

主要结局

USPHS criteria

时间窗: up to 2 years

Clinical evaluation of composite resin and compomer restorations in primary molars

次要结局

未报告次要终点

研究者

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

Esra Oz

Assistant professor

Suleyman Demirel University

研究点 (2)

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