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临床试验/NCT04095520
NCT04095520已完成不适用

Non-Carious Cervical Lesions Restored With Different Etching Methods and New Injectable Composite: One Year Clinical Follow-Up

Yuzuncu Yil University2 个研究点 分布在 2 个国家目标入组 27 人开始时间: 2019年9月1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
27
试验地点
2
主要终点
Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality

研究概览

简要总结

Non-carious cervical lesions are defined as loss of pathological material not associated with caries in the enamel-cement junction of the tooth. The etiology of these lesions has been defined as brush abrasion, acid-induced erosion and abstraction due to microstructure losses due to stress concentration in a particular region of the tooth. These lesions should be restored using minimally invasive techniques. The necessity of restorative treatment is directly related to the size of the lesion, sensitivity and aesthetic requirements. However, restorative procedures are often challenging because the cavity preparation does not provide adequate retention, and often the cervical end margin is positioned under the gingiva. This leads to contamination of the operation site with blood, saliva and gingival fluid.

Several restorative options have been proposed for the treatment of cervical caries-free lesions. However, due to their high aesthetic properties, improved adhesive capacity and mechanical properties, composites have been accepted as the most suitable choice. Clinical studies have demonstrated that marginal adaptation, marginal discoloration, and roughening methods for retention are the most important factors in the clinical performances of composite restorations in cervical lesions. Therefore, injectable composites with wettability and better adaptability to cavity margins have been introduced. However, the low filler contents of fluid composites and their weak mechanical properties compared to conventional composites have led researchers to doubt their use in caries-free cervical lesions. As a result of the developed material technology, injectable composites with high filler which have reduced polymerization shrinkage have been developed with simplified filler procedure. However, investigators have not encountered any studies investigating which etching technique this material will exhibit better clinical performance and comparing it with traditional pasty composites. The aim of this study is to evaluate the clinical performance of traditional paste type and injectable composites which will be made by using two different etching techniques.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cervical lesions in the mouth with multiples of 4 and 4,
  • Patients over 18 years of age and in permanent dentition,
  • Patients who do not have a pulpal or endodontic lesion on their teeth to be treated,
  • Patients without sensitivity to percussion in the teeth to be treated.

排除标准

  • Patients with any systemic disease,
  • Pregnant or suspected pregnancy and also breastfeeding patients,
  • Patients who are allergic to any dental material,
  • Patients with any periodontal disease,
  • Patients with poor oral hygiene,
  • In cases where the teeth are exposed to excessive load due to excessive rupture,
  • Cervical caries lesions,
  • Patients who continue orthodontic treatment,
  • Desensitizing agents or fluoride treatment.

结局指标

主要结局

Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality

时间窗: 1st day, 1st week, 6th month, 1st year

Postoperative (hyper-)sensitivity and tooth vitality of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Tooth integrity

时间窗: 1st day, 1st week, 6th month, 1st year

Tooth integrity of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Recurrence of Caries, Erosion, Abfraction

时间窗: 1st day, 1st week, 6th month, 1st year

Recurrence of Caries, Erosion, Abfraction of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Surface Staining

时间窗: 1st day, 1st week,6th month, 1st year

Surface staining of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Marginal Adaptation

时间窗: 1st day, 1st week, 6th month, 1st year

Marginal adaptation of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Patients View

时间窗: 1st day, 1st week, 6th month, 1st year

Patients view of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Surface Luster

时间窗: 1st day, 1st week,6th month, 1st year

Surface luster of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Retention

时间窗: 1st day, 1st week,6th month, 1st year

Fractures and retention of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Color Stability and Translucency

时间窗: 1st day, 1st week, 6th month, 1st year

Color Stability and translucency of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Wear

时间窗: 1st day, 1st week, 6th month, 1st year

Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Anatomic Form

时间窗: 1st day, 1st week, 6th month, 1st year

Anatomic form of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Evaluation the Changes of Periodontal response

时间窗: 1st day, 1st week, 6th month, 1st year

Periodontal response of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alperen Degirmenci

Assistant Professor

Yuzuncu Yil University

研究点 (2)

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