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临床试验/NCT03802539
NCT03802539Unknown不适用

5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial

Hacettepe University0 个研究点目标入组 38 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
38
主要终点
Retention Outcome

研究概览

简要总结

The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.

详细描述

Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries removal, the depth, length, and width of the cavity were measured. Lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (Glass liner II, Willmann & Pein GmbH Dental, Barmstedt, Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. The restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U and Cochran Q tests at a significance level of 5% (P < 0.05).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface

排除标准

  • Patients who were under the age of 18 years
  • Complex medical history
  • Severe or chronic periodontitis
  • Extreme carious activity
  • Heavy bruxism
  • Very deep or superficial carious lesions
  • Previously restored and abutment teeth

研究组 & 干预措施

Glass Liner

Experimental

Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin

干预措施: Glass Liner (Device)

No liner

No Intervention

Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin

结局指标

主要结局

Retention Outcome

时间窗: 5 years

1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

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

Uzay Koc

Principal Investigator

Hacettepe University

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