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临床试验/NCT02105896
NCT02105896已完成不适用

Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change from baseline to 6-year follow-up in retention.

研究概览

简要总结

Purpose: To evaluate the performance of several dental adhesives used for bonding tooth-colored fillings to teeth 6 years after the fillings have been placed.

Participants: Subjects which had participated in the study entitled "Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives" (IRB Study #07-0673).

Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a direct, visual examination. Close-up intra-oral clinical photographs of each filling will be made. An impression of the filling may be obtained.

The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673 is to evaluate the fillings placed according to the following characteristics: Retention; Color match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal adaptation and/or integrity; Post-operative sensitivity.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
25 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who participated in a 2007 study entitled "Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives" (UNC IRB Study #07-0673).

排除标准

  • 未提供

结局指标

主要结局

Change from baseline to 6-year follow-up in retention.

时间窗: sole visit (6 years post participation in related study).

Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.

次要结局

  • Change from baseline to 6-year follow-up in color match.(sole visit (6 years post participation in related study).)

研究者

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

Lee Boushell, DMD, MS

Associate Professor, Operative Dentistry

University of North Carolina, Chapel Hill

研究点 (1)

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