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临床试验/NCT03184025
NCT03184025Unknown不适用

Effect of Surface Sealant Application on Clinical Performance of HEMA Containing and HEMA-free Self-Etch Adhesives

Neslihan Tekçe0 个研究点目标入组 40 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.

研究概览

简要总结

The aim was to evaluate the clinical performance of HEMA-containing and HEMA-free all-in-one self-etch adhesives with and without a surface sealing process with a nanohybrid composite in occlusal caries restorations. The hypothesis is that the HEMA-containing and HEMA-free all-in-one self-etch adhesive and the surface sealing process would significantly effect clinical performance of occlusal restorations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients who received four direct Class I composite restorations, those with good oral hygiene with no active periodontal or pulpal diseases, whose permanent first or second molar required restorations for occlusal carious lesions with neighboring teeth and were in occlusion with antagonist teeth, and were willing to return for follow-up examinations as outlined by the investigators.

排除标准

  • •patients with uncontrolled parafunction, those presenting with poor oral hygiene and disinterested in or refused oral hygiene instructions, molars and premolars with carious lesions on a surface other than the occlusal surface and in continuity with the occlusal cavity, pulp exposure during caries removal procedure or cavities with the risk of pulp exposure, having spontaneous pain or sensitivity to percussion, and patients with periodontal or gingival disease.

研究组 & 干预措施

patients have class I caries

Other

patients have received four restorations which included HEMA containing and HEMA-free dentin adhesive with or without surface sealing

干预措施: dentin adhesive (Other)

结局指标

主要结局

Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.

时间窗: an average of 1 year

In restorations, retention rate, color match, wear or loss of anatomic form, marginal discoloration, caries, marginal adaptation, and surface texture were scored success or failure according to modified United States Public Health Service (USPHS) criteria. According to this criteria, success restorations received Alfa (A) or Bravo (B) scores. Alfa (A) represents the ideal clinical situation; Bravo (B) is the clinically acceptable. Failed restorations received Charlie (C) or Delta (D) scores. Charlie (C) is the clinically unacceptable situations where the restorations had to be replaced; Delta (D) is the situation where the restoration is fractured, mobile or missing and needed to be replaced immediately.

次要结局

未报告次要终点

研究者

发起方
Neslihan Tekçe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Neslihan Tekçe

Faculty of Dentistry

Kocaeli University

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