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临床试验/NCT04814836
NCT04814836进行中(未招募)不适用

Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods

Hacettepe University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
41
试验地点
2
主要终点
Retention,

研究概览

简要总结

To evaluate the clinical performance of the restorations by applying the universal adhesive in different modes under the influence of different surface treatments, with Erbium Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser and acid etching in non-carious cervical lesions.

详细描述

Forty-one patients (at least five non-carious cervical lesions) have participated in this study. The non-carious cervical lesions in each patient were divided into five groups (total-etch mode with phosphoric acid, selective-etch mode with phosphoric acid, total-etch mode with laser, selective-etch mode with laser and self-etch mode) according to different modes and application methods of universal adhesive (Clearfil Universal Bond Quick, Kuraray). Lesions were restored with a resin composite, Clearfil Majesty ES-2 (Kuraray). All restorative procedures were performed by a single operator. Restorations were evaluated at one week (baseline), at 6-, 12-, 18- and 24-month according to modified USPHS criteria (retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity, and secondary caries) by two experienced and calibrated investigators.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants were 18 years of age or older,
  • no possible health problems (such as allergies) related to resin-based restorations,
  • good general health,
  • having at least five non-carious cervical lesions.
  • The depth of the lesions were at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.
  • Exclusion Criteria
  • Participant had fewer than 20 teeth,
  • having poor oral hygiene,
  • uncontrolled periodontal disease,
  • xerostomia,
  • pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations,
  • having bleaching treatment or orthodontic treatment.

排除标准

  • 未提供

结局指标

主要结局

Retention,

时间窗: From baseline to 2 year the change of restorations was evaluated

The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material. Alpha: The restoration is present. Charlie: The restoration is absent.

Marginal Adaptation

时间窗: From baseline to 2 year the change of restorations was evaluated

Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border. Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable. Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.

Marginal Discoloration

时间窗: From baseline to 2 year the change of restorations was evaluated

The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage. Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.

Color match

时间窗: From baseline to 2 year the change of restorations was evaluated

Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.

Post-op Hypersensitivity

时间窗: From baseline to 2 year the change of restorations was evaluated

Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.

Secondary Caries

时间窗: From baseline to 2 year the change of restorations was evaluated

Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure. Alpha: Absent. Charlie: Present; clinically unacceptable.

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

A Ruya Yazici

Professor

Hacettepe University

研究点 (2)

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