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临床试验/NCT05623423
NCT05623423已完成不适用

Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin a Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年11月30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
26
试验地点
2
主要终点
Shade match

研究概览

简要总结

Evaluation of clinical performance of class IV restoration using organically modified ceramic (ORMOCER) in comparison to a Methacrylate Based Composite Resin: A randomized clinical trial

详细描述

Statement of the problem:

Resin composites have been the most popular material in esthetic dentistry since 1960's. Esthetic restorative material should resemble the natural tooth; in both color match and stability, and should have adequate strength, wear and sealing characteristics

. Longevity of anterior restorations varied in earlier studies depending on the restorative material and cavity class. Involvement of the incisal angle in anterior teeth resulted in accompanied reduction in average survival time. In contrast to class I, II, III and V cavity configurations, class IV restorations are stressed at the incisal angle, posing a challenge to the tooth restoration interface. Because the majority of class IV restorations lack mechanical retention; the tooth-bonded interface faces additional obstacles. In addition, color is one of the most important factors of esthetic restorations, since color change may be due to intrinsic factors as; changes in the filler, matrix and silane coating as well as extrinsic staining; as absorption of stains, chemical reactivity, diet and oral hygiene. But the recent advances in the resin composite restoration in their monomer chemistry, filler type and structure have been continuously developed to improve their mechanical and physical properties.

Rationale:

In order to optimize the properties of the material and facilitate deeper light transmission, manufacturers incorporated an advanced composite filler technology and resin matrix modifications by introducing Organically Modified Ceramics with pure silicate technology showing superior material properties, which was claimed to be better than Methacrylate Based Composite Resin. Moreover, polymerization shrinkage stresses depend on many factors, like composition of resin matrix, quantity of filler and degree of conversion. Ormocer induces polymerization as a result of a matrix of long inorganic silica chains with organic lateral chains. This type of Ormocer enhances aesthetics, color stability, abrasion resistance, and reduces polymerization shrinkage and surface roughness due to the presence of ceramic polysiloxane, which has low degree of polymerization shrinkage (1.25%)

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • participant:
  • Age of patient (18-40) years old.
  • Good oral hygiene.
  • Having no active pulpal or periodontal conditions.
  • Normal Occlusion.
  • Able to return for follow-up assessments as illustrated by the examiners. -

排除标准

  • participant:
  • Patients with Edge-to-Edge occlusion.
  • Patients with high caries index.
  • Patients with uncontrolled para-functional habits (e.g. bruxism or clenching).
  • Patients with inadequate oral hygiene.
  • Patients with periodontal or gingival conditions.
  • Patients with orthodontic appliances.
  • Patients with spontaneous pain or sensitivity to percussion
  • Pregnant Patients -

结局指标

主要结局

Shade match

时间窗: T3: 1 year.

measured by Modified USPHS

次要结局

  • a) Retention rate(T3: 1 year)

研究者

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

Lilly Assem Mousa Ahmed

Investigator, data entry & corresponding author B.D.S. October University for Modern Sciences and Arts (2017). Teaching Assistant at MSA University, 6th Of October, Egypt.

Cairo University

研究点 (2)

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