跳至主要内容
临床试验/NCT04897724
NCT04897724Unknown不适用

The Clinical Performance of Direct Posterior Composite Restorations in Patients With Amelogenesis Imperfecta

Neslihan Tekçe0 个研究点目标入组 15 人开始时间: 2014年9月2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
15
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

In AI patients, adhesion still remains the first option in order to achieve an early, minimally invasive intervention, and the altered enamel still represents an acceptable substrate for bonding in some AI variants. Many cases have revealed that the direct composite restorations provide satisfactory esthetic and functionality in restoring AI-affected teeth. The objective of this study was to evaluate the clinical performance of composite restorations in posterior teeth in patients afflicted with Amelogenesis Imperfecta using nanohybrid and nanofill composite materials

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
14 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •the patient had to require treatment due to carious lesions in one or more surface of molars and premolars,
  • •AI diagnosis had to be made, which had to be verified clinically, and also confirmed by anamnestic family history, or clinical examination concerning Witkop's classification

排除标准

  • •patients with developmental enamel defects of other origins such as fluorosis, molar incisor hypomineralization;
  • •AI was associated with other oral developmental or systemic disorders, and dental abnormalities such as open-bite, deep-bite, and cross-bite;
  • •patients who were unable to provide their informed consent.

研究组 & 干预措施

patients have carious lesions in one or more surface of molars and premolars

Other

patients received direct composite restorations using a nanohybrid and a nonofil composite restorations

干预措施: dental composite (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

Associate Professor

Kocaeli University

相似试验