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Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)

2021年11月19日 更新者：Alshimaa Nasser Mahmoud

clinical evaluation of the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.

Hypothesis: Could the preheated composite affect the temperature of the pulpal floor

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
      • Minya、埃及、61519
        • Faculty of Dentistry - Minia University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy men and women patients of 25-45 years.
  • They should have a good oral hygiene level.
  • Presence of at least two posterior class I or II carious lesions to be restored with two different composite resin restorations.
  • All carious lesions in selected patients didn't close to the pulp in the preoperative radiograph.
  • No preoperative pain.
  • Normal occlusal contact with opposing teeth.
  • No history of periodontal treatment, including periodontal surgery, in the past year.
  • All patients had to sign a written consent before being included.
  • A good likelihood of recall availability.

Exclusion Criteria:

  • patient with severe periodontitis or severe erosion damage.
  • patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
  • If analgesics or antibiotics had administered by the patient during the past 12 hours preoperatively as it might alter their pain perception.
  • patients reported bruxism or clenching.
  • Greater than grade I mobility or pocket depth greater than 5mm.
  • Non-restorable teeth or hopeless teeth.
  • Immature teeth.
  • Radiographic evidence of external or internal root resorption.
  • Alcoholic and smoker patients.
  • Pregnant or breastfeeding ladies.
  • Patients who had physical disabilities, or who are unable to brush their teeth.
  • Individuals who had sensitive teeth but with one of the following conditions was excluded from the study, teeth with large restoration, abutment of teeth of removable partial dentures, dental restorations, abutment of teeth of removable partial dentures, enamel cracks, leakage of fillings or other restorations teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
  • Patients who had non-carious lesions like attrition, erosion, abrasion or abfraction.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for a recall appointment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Admira 50º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C
其他：preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
其他名称：
  • warming of resin composite
有源比较器：Admira 70º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C
其他：preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
其他名称：
  • warming of resin composite
有源比较器：Viscalor 50º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C
其他：preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
其他名称：
  • warming of resin composite
有源比较器：Viscalor 70º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C
其他：preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
其他名称：
  • warming of resin composite

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
pulpal floor temperature and restoration temperature
大体时间：one year

evaluation the effect of preheating BIS GMA free resin composite at different temperature on temperature change of pulpal floor and restoration and compare it with BIS GMA containing resin composite

All readings were taken with the presence of a rubber dam and recorded in Celsius (°C).

Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

次要结果测量

结果测量
措施说明
大体时间
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
大体时间：one year
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

其他结果措施

结果测量
措施说明
大体时间
The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
大体时间：one year
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alshimaa Nasser Mahmoud

调查人员

  • 研究主任：Mona I Riad, Professor、Professor at Faculty of Dentistry Cairo University
  • 研究主任：Nermin A Mahmoud, Lecturer、Lecturer at Faculty of Dentistry Minia University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月1日

初级完成 (实际的)

2021年6月15日

研究完成 (实际的)

2021年9月28日

研究注册日期

首次提交

2021年11月8日

首先提交符合 QC 标准的

2021年11月19日

首次发布 (实际的)

2021年12月1日

研究记录更新

最后更新发布 (实际的)

2021年12月1日

上次提交的符合 QC 标准的更新

2021年11月19日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 490

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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