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临床试验/NCT06562868
NCT06562868已完成不适用

Comparison of the 2-year Clinical Performances of Class II Restorations Using Different Restorative Materials

TC Erciyes University2 个研究点 分布在 2 个国家目标入组 110 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
FDI World Dental Federation Evaluation Criteria

研究概览

简要总结

The aim of this study is to compare the clinical success of different filling materials used in the treatment of dental caries. Systemically healthy individuals with good oral hygiene and interproximal caries in their posterior teeth participated in the study. Participants underwent initial radiographic and intraoral examinations. Three different filling materials were applied to the participants' teeth. The restorations were evaluated at baseline, 1 year, and 2 years.

详细描述

The aim of this study was to evaluate the clinical performance of Class II carious defects restored with traditional posterior composite, bulk-fill composite, and high-fill flowable composite resin according to the World Dental Federation (FDI) criteria at 12-month and 24-month intervals. In this study, 110 patients underwent initial radiographic and intraoral examinations. Radiographically, 259 teeth with interproximal caries at D1 and D2 levels were identified. All restorations in the study were performed by the same dentist. Before starting the restoration procedure, local anesthesia was administered to the tooth or teeth. The caries were removed and the preparation was completed. Following the washing and drying of the cavities, cotton rolls and saliva ejectors were placed to ensure isolation. An appropriate matrix system and wooden wedges were applied. A 0.2% chlorhexidine gluconate solution was used as the cavity disinfectant. Subsequently, the enamel surfaces of the teeth were roughened for 30 seconds using a selective etching technique with 37% phosphoric acid. The universal dental adhesive system was applied according to the manufacturer's instructions..The first group received bulk-fill composite resin (Filtek One Bulk Fill Restorative), the second group received traditional posterior composite (Clearfil Majesty Posterior ), and the third group received high-filler flowable composite resin. The same universal dental adhesive system was used for all groups. All restorations were evaluated by two experienced dentists according to the FDI evaluation criteria at baseline,1 year and 2 years. In cases where discrepancies were observed between the two examiners, the assessment was based on a consensus decision made by both dentists. Restorations were evaluated and scored separately for each criterion on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement).

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 (Participant, Outcomes Assessor)

盲法说明

While the materials used for the restorations were known to the practitioner, neither the patients nor the specialist dentists conducting the follow-up examinations were aware of them.

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

  • The patient has no systemic disease
  • The patient should be over 18 years of age
  • The patient should have good periodontal status
  • Teeth to be restored should be symptomless and vital
  • Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth
  • Teeth that have class II caries lesion in external and middle 1/3 of dentine thickness radiographically

排除标准

  • Xerostomia and bruxism
  • Absence of adjacent and antagonist teeth
  • Extremely poor oral hygiene, severe or chronic periodontitis
  • Pregnant or lactating women
  • Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
  • The patients who are undergoing orthodontic treatment

结局指标

主要结局

FDI World Dental Federation Evaluation Criteria

时间窗: two years

The FDI evaluation criteria, developed by the World Dental Federation, are used to assess the clinical performance of dental restorations. The restorations were evaluated separately for each criterion and scored on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement).

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

Sevim Hancer Sarica

Research Assistant

TC Erciyes University

研究点 (2)

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