Comparison of Two Universal Composites in Posterior Teeth
2016年8月30日 更新者：Zeynep Bilge Kutuk、Hacettepe University
Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.
研究概览
详细说明
A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15)
were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions.
Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria.
Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months.
The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p<0.05).
研究类型
介入性
注册 (实际的)
40
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
-
-
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Ankara、火鸡、06100
- Hacettepe University School of Dentistry
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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
18年 至 38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:
- a need for at least two but not more than four posterior tooth-colored restorations
- the presence of teeth to be restored in occlusion
- teeth that were symptomless and vital
- a normal periodontal status
- a good likelihood of recall availability.
Exclusion Criteria:
- partly erupted teeth
- absence of adjacent and antagonist teeth
- poor periodontal status
- adverse medical history
- potential behavioral problems.
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Charisma
applied randomly
|
The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.
其他名称：
|
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有源比较器：Charisma classic
applied randomly
|
The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.
其他名称：
|
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 |
|---|---|---|
|
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
大体时间：The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
|
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
|
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
大体时间：The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
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"Fracture of material and retention"; "Marginal adaptation"
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The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.
大体时间：The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
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"Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)"
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The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
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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。
调查人员
- 研究主任：Sevil Gurgan, DDS, PhD、Hacettepe University School of Dentistry
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gurgan S, Vural UK, Kutuk ZB, Cakir FY. Comparison of two universal composites in posterior teeth: preliminary report. J Dent Res (Spec Iss 94 B): 308, 2015
- Gurgan S, Koc Vural U, Kutuk ZB, Cakir FY. Does a new formula have an input in the clinical success of posterior composite restorations? A chat study. Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.
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
2014年5月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2016年8月24日
首先提交符合 QC 标准的
2016年8月30日
首次发布 (估计)
2016年9月5日
研究记录更新
最后更新发布 (估计)
2016年9月5日
上次提交的符合 QC 标准的更新
2016年8月30日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.