跳至主要内容
临床试验/NCT07227688
NCT07227688进行中(未招募)不适用

Evaluation of the Proximal Anatomical Form Quality of Different Precontoured Sectional Matrix Systems in Complex Proximal Posterior Resin Composite Restorations: Randomized Clinical Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Number of participants with a change in the proximal anatomical form using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations

研究概览

简要总结

Evaluation of the proximal anatomical form quality of different precontoured sectional matrix systems in complex proximal posterior resin composite restorations using Fédération Dentaire Internationale' (FDI) clinical criteria for the evaluation of direct and indirect restorations

详细描述

The importance of the interdental anatomy of a class II direct composite restoration is one of the most underestimated topics in direct posterior composite restorations. The proximal emergence profile of the restoration and the contact area should be designed to maximize arch continuity and to minimize food impaction. A thorough knowledge of proper contacts and contours and how they ought to be duplicated as well as predisposing factors for proximal contact loss as proximal caries, embrasure size and position, and marginal ridge location and thickness, all of which contribute to achieving ideal occlusal harmony.

Conventional circumferential matrix systems produced poor proximal contact points with proximal overhangs or open contacts, and they failed to produce optimum contact points; thus, their usage should be prohibited.

It was found that, optimum contact points were highly associated with the sectional matrix system; there was a 70% lower risk for non- optimum contact points than the circumferential matrix system. Open and tight contacts were highly associated with the circumferential matrix system regardless of operator experience. Sectional matrix systems with separation rings should be implemented as the first choice in clinical decision making for proximal posterior restorations.

Although in vitro and in vivo studies showed that the use a contoured sectional metal matrix band with a separation rings results in optimum contact point and emergence profile, its use is technique sensitive due to rounded contours and thin thickness of matrices, which can cause a depression or bending in the matrix material during placement, rendering it unusable. Also, this matrix systems have shortcomings and does not give the expected result in all class II cavities. The variation in depth, width of the box, distance between the cervical cavity margin and the adjacent tooth requires customization of the interproximal space.

As the main objective is to recreate proximal contacts and contour that mimic the natural teeth making this area self-cleansable, preserving the periodontium, improving the restoration durability as well as maintaining the mesio-distal dimension of either dental arch. This mission is more complicated with badly broken-down teeth. By defining a badly destructed tooth we can say that it is a tooth that has lost a significant amount of tooth material which may be due to caries affection, fractures, or even extensive endo treatments. The result is that the remaining tooth structure becomes friable and weakened and presents a challenge during restoration due to increased distance between the cervical cavity margin and the adjacent tooth and the situation is more complicated if part of the buccal and lingual walls are missing making the ordinary sectional matrix liable to collapse after placing the separation rings.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with posterior complex class II cavities to be restored with resin composite restorations.
  • •18 - 45 years.
  • •Males or Females.
  • •Good oral hygiene.
  • •Co-operative patients approving to participate in the study.

排除标准

  • •Poor oral hygiene.
  • •Allergic history concerning methacrylates
  • •Evidence of parafunctional habits.
  • •Presence of malalignment of teeth

研究组 & 干预措施

BioFit Posterior Matrix System

Active Comparator

BioFit Posterior Matrix System (Bioclear, Tacoma, Washington, USA).

干预措施: BioFit Posterior Matrix System (Device)

Sectional matrix: Classic ring system

Experimental

Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)

干预措施: Sectional matrix: Classic ring system (TOR VM, Moscow, Russia) (Device)

Saddle system

Active Comparator

Saddle system (TOR VM, Moscow, Russia)

干预措施: Saddle system (TOR VM, Moscow, Russia) (Device)

结局指标

主要结局

Number of participants with a change in the proximal anatomical form using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations

时间窗: Immediately after restoration placement at the baseline

1. Proximal contact point with the aid of visual examination and 25-/50-/100-μm metal blades. 2. Form and contour utilizing visual examination and radiographic assessment. For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).

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

Mona mahmoud Abd Elrahman

Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Cairo University

研究点 (1)

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