跳至主要内容
临床试验/NCT06870188
NCT06870188已完成不适用

Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study

Muğla Sıtkı Koçman University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
clinical success

研究概览

简要总结

The aim of this prospective, randomized, parallel-group clinical study is to compare the 6- and 12-month clinical performances of direct composite restorations applied to endodontically treated posterior teeth with or without the use of fiber-reinforced composite material in individuals with parafunctional habits.

Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of teeth. The possible outcomes of bruxism include wear and/or fractures in the teeth and restorations. Therefore, the choice of restorative methods and materials for restorations in bruxist individuals is of great importance. Direct adhesive restorations are the first treatment option for endodontically treated teeth with no excessive material loss and/or those that have lost vitality due to trauma. Over the past decade, the use of fiber-reinforced materials has been recommended to prevent catastrophic fractures. Fiber-reinforced materials have been developed and introduced to the market based on the idea that a restorative material that distributes or absorbs stress in high-stress areas will protect the underlying tooth structure.

Although there are numerous studies on the mechanical durability of restorative treatments for endodontically treated teeth in cases with parafunctional habits, there are limited clinical studies regarding the clinical performance of these methods.

The study included 32 premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups (n=16): Group 1: fiber-reinforced composite restoration (EverX flow, GC) (FRCR), Group 2: composite restoration (Gneal Posterior, GC) (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers aged 18 and above Cases where restoration was performed immediately after the completion of root canal treatment on posterior teeth Endodontically treated posterior teeth that required replacement of the old restoration due to secondary caries or fractures Cases without pulpal symptoms Posterior teeth classified as Class 1 and Class 2 according to cavity classification Teeth with a remaining wall thickness of at least 3 mm Presence of parafunction Teeth with a natural tooth in the opposing arch and adjacent teeth on both proximal sides

排除标准

  • Individuals who are not volunteers
  • Cases with ongoing pulpal symptoms
  • Posterior teeth with cusp loss
  • Teeth with root canal filling that is at least 2 mm shorter than the radiographic apex
  • Individuals unable to attend periodic follow-up visits
  • Individuals with a Gingival Index score greater than 1
  • Severe periodontal disease
  • Presence of systemic diseases
  • Individuals with allergic reactions to any of the materials to be used
  • Pregnant or breastfeeding women

结局指标

主要结局

clinical success

时间窗: 6 and 12 months-follow-up

The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic and biological criteria according to the FDI criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Yilmaz

Asistant professor doctor

Muğla Sıtkı Koçman University

研究点 (2)

Loading locations...

相似试验