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Marginal Adaptation, Shade Matching, of Polychromatic Feldspathic VS Polychromatic Hybrid Ceramic Laminate Veneer

2021年6月29日 更新者:Kamilia Faisal Abdulkader、Cairo University

Marginal Adaptation, Shade Matching, and Patient Satisfaction of Polychromatic Feldspathic Laminate Veneer Versus Polychromatic Hybrid Ceramic Laminate Veneer.(Randomize Control Trial)

The aim of the present study is to evaluate the marginal adaptationو shade matching and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer.

研究概览

详细说明

PICO P: Population: patients' needs esthetic anterior veneers. I: Intervention: Multicolor hybrid ceramic laminate veneers. C: Comparison: Multicolor feldspathic laminate veneers. O: Outcome: primary: Marginal adaptation. secondary:1 Shade matching 2. Patient satisfaction. S: Study design: Randomized controlled clinical trial. T Time: One year. Research question Will polychromatic hybrid ceramic laminate veneer improve the marginal adaptation, shade matching, and patient satisfaction when compared to polychromatic feldspathic porcelain laminate veneer? Statement of the problem Anterior all-ceramic restoration exhibits esthetic challenge due to color gradient of the tooth nature from cervical to incisor, subsequently, the monochromatic CAD/CAM blocks need external stains which require more time and effort moreover it may leach out over time.

Since the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks, which make it the first choice in the esthetic zone, on the other hand, it has low strength properties that need careful handling before cementation consequently, the hybrid ceramic overcomes the brittleness characteristic of felspathic ceramics with new material that has comparable esthetic and translucency with polychromatic feature and resilience properties.

Multi-shaded blocks have recently been introducing to the market due to a lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. For that, the current study will directly evaluate the shade matching of feldspathic polychromatic porcelain blocks versus hybrid ceramic polychromatic blocks to enhance the multichromatic shade matching of laminate veneers restorations.

Rationale Decision-making for the treatment of esthetic areas performed to achieve highly esthetic outcomes the primary factor for achieving this goal is the material used which, should be of a high shade matching the nature color transition of the natural teeth from cervical to incisal third. Probably the new Enovation of multicolor hybrid ceramic and feldspathic porcelain will solve this problem.

Aim of the study:

The present study aims to evaluate the marginal adaptation, shade matching, and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer.

Null hypothesis:

There will be no difference regarding the marginal integrity, shade matching, and patient satisfaction between multicolored feldspathic porcelain anterior laminate veneers and hybrid ceramic multi-color anterior laminate veneers.

III. Methods A) Participants, interventions, and outcomes 9- Study setting: This study will be carried out on patients enrolled from the outpatient clinic in fixed prosthodontics clinic, Faculty of Dentistry, Cairo University 10- Intervention:

10.a.i. Examination and diagnosis:

  • Selection and examination of the patients according to inclusion and exclusion criteria proper scaling and polishing procedure will be done
  • Primary impressions will take to produce a study cast. The patients will instruct to maintain good oral hygiene by using a toothbrush twice daily.
  • Taking a pre-operative professional photo. 10.a.ii. Tooth preparation procedure:

    1. Recording the sulcus depth and gingival condition before preparation.
    2. Conservative tooth preparation will be prepared after local anesthesia has been given as required.
    3. Full coverage preparation will be carried out.

    3. After tooth preparation, adequate 2ry Impression using nonaqueous elastomeric impression materials and bite registration will be taken.

    5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non-Eugenol Zinc Oxide temporary cement.

    10.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the viologen system of appropriate shade. The finished Bio HPP crown will cement with adhesive resin cement according to manufacturer instructions.

    10.b. Criteria for discontinuing: Restoration will be removed when there are any signs of leakage, fracture, or severe post-operative pain due to pulpal response and replaced by a temporary restoration cemented with Ca (OH) cement to elevate pain.

    10.c. Strategies to improve adherence to intervention protocol:

  • ''In the first visit, a Face to Face adherence session will hold for the patient to be informed about the study steps and how to maintain oral hygiene measures.

Further sessions will occur at the follow-up visits. Participant patients will ask about any problems they are having. Patients will be recalled every three months for one year for follow-up visits.

10.d. Permitted or prohibited interventions: Oral hygiene measures are permitted for enhanced results while using hard toothbrushes or abrasive containing toothpaste after the intervention is prohibited.

11- Outcomes:

- The following assessment surveys (clinical evaluations) will be carried out for both groups: T0 = Preoperative phase: clinical records, periapical radiograph, intraoral photographs, and study casts.

T1 = immediately after final restoration delivery: intraoral photographs. T2 = postoperatively: assessment of the marginal adaptation, shade matching, and patient satisfaction.

研究类型

介入性

注册 (预期的)

26

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria: All subjects are required to be:

  1. patients age range (18-50 years) old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations
  3. Psychologically and physically able to withstand conventional dental procedures
  4. Patients in a need of anterior veneers.
  5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

  1. Patient less than 18 or more than 50 years
  2. Patient with active persistent periodontal diseases
  3. Patients with poor oral hygiene and uncooperative patients
  4. Patients need a smile design for the esthetic zone.
  5. Patients in the growth stage with partially erupted teeth
  6. Psychiatric problems or unrealistic expectations
  7. patient with non-vital teeth.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Multicolor feldspathic ceramic laminate veneers
the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties.
the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties.
实验性的:Multicolor hybrid ceramic laminate veneers.
Multi-shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers.
Multi shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Marginal adaptation
大体时间:one year
Modified USPHS criteria Alfa: Closely adapted (score 1), no visible crevice Bravo: Visible crevice, explorer will penetrate (score 2) Charlie: Crevice in which dentin is exposed (score3) Charlie: Crevice in which dentin is exposed
one year

次要结果测量

结果测量
措施说明
大体时间
Shade matching
大体时间:one year
Modified USPHS criteria Alfa: Matches tooth (score1) Bravo: Acceptable mismatch (score2) Charlie: Unacceptable mismatch (score3)
one year
Patient satisfaction
大体时间:one year
Questionnaire (good and excellent (score1), acceptable (score2), Non-acceptable (score3)
one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年12月10日

初级完成 (预期的)

2024年5月27日

研究完成 (预期的)

2024年11月20日

研究注册日期

首次提交

2021年6月22日

首先提交符合 QC 标准的

2021年6月22日

首次发布 (实际的)

2021年6月28日

研究记录更新

最后更新发布 (实际的)

2021年7月1日

上次提交的符合 QC 标准的更新

2021年6月29日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 6221

计划个人参与者数据 (IPD)

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Multicolor fieldspathic ceramic laminate veneers.的临床试验

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