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临床试验/NCT04401618
NCT04401618已完成不适用

Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students

Western University, Canada1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Post-Operative Sensitivity

研究概览

简要总结

Brief Summary: Retrospective study to evaluate the clinical performance of two restorative materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V carious and non-carious cervical lesions restored by dental students.

详细描述

The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious cervical lesions restored by dental students. Ninety-six (96) restorations performed with either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS (United States Public Health Systems) criteria by two independent investigators at two follow-up evaluations (two years apart). The Fisher statistical test was used to compare USPHS criteria and examine significant differences by setting p<0.05 for statistical significance and the Kaplan-Meier algorithm was used to calculate the survival probability.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over the last three years.

排除标准

  • Class V Restorations placed outside of the dental school
  • Class V Restorations that used other restorative materials Class V Ionomer restorations (RMGI and GIC0 placed before three years on the time of evaluation.

结局指标

主要结局

Post-Operative Sensitivity

时间窗: 2 years

Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)

Surface Roughness

时间窗: 2 years

Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)

Marginal Integrity

时间窗: 2 years

Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)

Secondary Caries

时间窗: 2 years

No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)

Anatomic Form

时间窗: 2 years

Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)

Color match

时间窗: 2 years

No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)

Marginal Discolouration

时间窗: 2 years

No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Jacinta Santos

Associate Professor

Western University, Canada

研究点 (1)

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