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临床试验/NCT04129047
NCT04129047Unknown4 期

Shade Matching of Omnichroma (One Shade Universal Composite) Versus a Microhybrid Composite in Class V Restorations. A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
38
试验地点
1
主要终点
Shade matching (visually and using image analysis)

研究概览

简要总结

Background Resin composites are effective in restoring damaged teeth due to their good esthetics, high surface gloss, and clinically acceptable wear resistance1. One of the most challenging tasks a dentist has to confront in daily practice is matching the color of composite restorations used in anterior teeth2.

Problem The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception3. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.4. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits 5. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment6.

Rationale Shade matching has been a time consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results7. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure 8. Introduction of Omnichroma by Tokuyama is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure.

Aim The aim of this study is to evaluate the shade matching ability of a new single shade composite (Omnichroma; Tokuyama) compared to a conventional multiple shade microhybrid composite in the restoration of class V restorations using USPHS criteria

详细描述

Background and rationale:

Research question:

In class V restorations will there be a difference in shade matching between Omnichroma (one shade) universal composite and a microhybrid (multiple shade) universal composite?

Statement of the problem:

The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment.

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
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with carious class V lesions
  • Non-carious cervical abfraction lesions
  • Young adult Males or female
  • Good oral hygiene
  • Co-operative patients approving to participate in the study

排除标准

  • Patients with a compromised medical history.
  • Severe or active periodontal disease
  • Severe medical complications
  • Erosive lesions
  • Lack of compliance and rampant caries

研究组 & 干预措施

Omnichroma (one shade universal) composite by Tokuyama

Experimental

class V cavities will be made under isolation. Omnichroma (one shade universal) composite by Tokuyama will be placed according to guidelines.

干预措施: Omnichroma (one shade universal) composite by Tokuyama (Drug)

A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA)

Active Comparator

class V cavities will be made under isolation. A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) will be placed according to guidelines.

干预措施: A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA (Drug)

结局指标

主要结局

Shade matching (visually and using image analysis)

时间窗: Baseline after 1 week

To evaluate the shade matching ability of the newly introduced single shade composite compared to a conventional multiple shade micro hybrid composite. Assessment will be done visually using Modified USPHS Criteria and by image analysis. Image analysis will be done by comparing LAB values using Adobe Photoshop

次要结局

  • Color stability (visually and using image analysis)(Color stability between baseline, 3 months and 6 months)

研究者

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

Mohamed Mohamed Aly Aref

Resident

Cairo University

研究点 (1)

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