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临床试验/NCT06393270
NCT06393270已完成不适用

5-year Clinical Follow-up of Bulk-fill Restorative Materials in Class II Restorations

Selcuk University1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2017年11月1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
192
试验地点
1
主要终点
Marginal Discoloration

研究概览

简要总结

Materials to be used as permanent filling materials in Class II restorations are still an essential field of study. This study aims to evaluate the 5-year clinical performance of Class II restorations performed with different bulk-fill restorative materials.

The study was planned as an observational clinical trial. In the study, Class II restorations performed with Tetric Bulk Fill (TBF) and Filtek Bulk Fill (FBF) composites and Equia Forte Fil (EF) will be evaluated. Fifty-one patients and 119 restorations will be included in the study. Restorations will be assessed in terms of modified United States Public Health Service (USPHS) criteria during the 5th year. Cochran Q, Pearson chi-square, and Fisher-Freeman-Halton tests will be used for statistical analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were;
  • older than 18 years old
  • had good general health and oral hygiene
  • had interface restorations of similar size in their premolars and molars
  • were able to attend control appointments were included The teeth were determined as follows;
  • in contact with the opposing tooth
  • exposed to normal occlusal forces on the dentition
  • restoration width not exceeding 1⁄2 of the intercuspal distance
  • normal response to vitality tests without periodontal pathology

排除标准

  • Patients with;
  • poor oral hygiene
  • those with active periodontal disease
  • those with severe bruxism
  • pregnant and lactating women
  • endodontically treated teeth were excluded from the study

结局指标

主要结局

Marginal Discoloration

时间窗: 5th year.

At the control appointment, it was determined whether there was any color change at the edges of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.

Color Match

时间窗: 5th year.

At the control appointment, it was determined whether the restoration's color harmony with the adjacent tooth tissue was maintained. The scale used includes the characters A, B, and C. A is the best clinical result.

Marginal Adaptation

时间窗: 5th year.

At the follow-up appointment, it was determined whether there was any deterioration in the marginal adaptation of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.

Secondary Caries

时间窗: 5th year.

At the follow-up appointment, it was determined whether there was any decay under the restoration. The scale used includes the characters A and C. A is the best clinical result.

Surface Texture

时间窗: 5th year.

At the control appointment, it was determined whether the restoration surface had a defect. The scale used includes the characters A, B, and C. A is the best clinical result.

Retention

时间窗: 5th year.

At the control appointment, it was determined whether there was material loss in the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.

Anatomical Form

时间窗: 5th year.

At the control appointment, it was determined whether the restoration maintained its anatomical form. The scale used includes the characters A, B, and C. A is the best clinical result.

Postoperative Sensitivity

时间窗: 5th year.

At the follow-up appointment, it was determined whether there was postoperative sensitivity after the restorative procedure. The scale used includes the characters A, B, and C. A is the best clinical result.

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

Merve Gurses

Assistant Professor

Selcuk University

研究点 (1)

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