跳至主要内容
临床试验/NCT05801458
NCT05801458尚未招募不适用

Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique Versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial

Cairo University0 个研究点目标入组 50 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Change from baseline in Marginal Discoloration at 3,6,12 & 18 months

研究概览

简要总结

Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial

详细描述

Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.

One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.

Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.

Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.

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
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants:
  • Adult Patients (25-45).
  • Good oral hygiene (plaque index score 0 or 1).
  • Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
  • Vital teeth with a normal appearance and morphology.
  • Primary carious lesions in molar teeth.

排除标准

  • Participants:
  • Patients with bad oral hygiene.
  • Patients with known allergic or adverse reaction to the tested materials.
  • Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.
  • Non-vital, fractured, or cracked teeth.
  • Teeth with secondary caries or in need of replacement of existing restorations.
  • Defective restorations adjacent to or opposite the tooth restored in the study.
  • Rampant caries, atypical extrinsic staining of teeth.

结局指标

主要结局

Change from baseline in Marginal Discoloration at 3,6,12 & 18 months

时间窗: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months

Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).

次要结局

  • Change from baseline in Color Match at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)
  • Change from baseline in Retention of Restoration at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)
  • Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)
  • Change from baseline in Marginal Integrity at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)
  • Change from baseline in Surface Roughness at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)
  • Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)
  • Change from baseline in Secondary Caries at 3,6,12 & 18 months(T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months)

研究者

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

Amira Ahmed Mahmoud Mohamed

Operator, main investigator and corresponding author

Cairo University

相似试验