跳至主要内容
临床试验/NCT04943120
NCT04943120已完成不适用

Clinical Evaluation of "Snow-Plow" Technique Versus Bulk Fill Technique in Restoration of Class II Cavities: Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年8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
32
试验地点
2
主要终点
clinical performance

研究概览

简要总结

The aim of the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities.

详细描述

  1. With limited evidence-based information about the clinical performance of resin composite in class II cavities. it is beneficial to compare the newly introduced "snow-plow' technique using a randomized clinical trial to test the null hypothesis that this new technique has the same clinical performance.
  2. The comparator will be the bulk fill technique as an alternative to the conventional layering technique. This is because it has shown lower polymerization shrinkage when comparing it to the conventional composite. Bulk fill has reduced the chair time for the patient. It is done by the application of 4mm increment and cured at once.
  3. Patients are selected according to the eligibility criteria discussed in the following section.
  4. local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. A standard class II cavity will be prepared at the two-surface cavities.
  5. The preparation will be performed using rotary instrumentation for cavity preparation by a water-cooled high-speed hand-piece by the same operator.
  6. The teeth are then restored using one of the two techniques according to their allocation with the same steps discussed in the different arms.
  7. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • class II carious lesions in premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

排除标准

  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion or occlusal contacts or history of bruxism.
  • Severe periodontal affection.

结局指标

主要结局

clinical performance

时间窗: 12 months

USPHS Criteria

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

Mariam Mohamed Ahmed Gomaa

Main Investigator

Cairo University

研究点 (2)

Loading locations...

相似试验