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临床试验/NCT05861908
NCT05861908进行中(未招募)不适用

Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation

Mansoura University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Esthetic Properties of restorations

研究概览

简要总结

The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.

详细描述

Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation 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 (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Good oral hygienic
  • Patient aging 18-35 year
  • Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal)
  • Carious lesion in the external and middle third of dentin thickness
  • ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically.
  • Maxillary or mandibular first or second molars
  • Tooth with antagonist and adjacent mesial and distal tooth contact,
  • Normal response to a vitality test.

排除标准

  • Poor oral hygiene
  • Severe or chronic periodontitis
  • Heavy bruxism
  • Occlusion fewer than 20 teeth
  • Sensitivity to resin-based material.
  • Patients with orthodontic treatment
  • Patients on pregnancy or lactation
  • chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs
  • Patient potentially unable to attend recall visits
  • Teeth would need direct pulp capping or
  • Teeth act as abutment for fixed or removable prosthesis.

结局指标

主要结局

Esthetic Properties of restorations

时间窗: Three years Follow up

criteria that evaluated according to Modified FDI(International Dental Federation) world dental federation is: 1. Surface luster 2. Staining 3. Color match and translucency 4. Esthetic and Anatomic form Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor

Functional Properties of restorations

时间窗: Three years Follow up

criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: 1. Fractures of material and retention 2. Marginal adaptation 3. Occlusal contour and wear 4. Proximal anatomical form 5. Patient's view Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor

Biological Properties of restorations

时间窗: Three years Follow up

criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: 1. Post-operative (hyper-sensitivity) and tooth vitality 2. Recurrence of caries, erosion, abfraction 3. Tooth integrity (enamel cracks, tooth fractures) 4. Periodontal 5. Adjacent Mucosa 6. Oral and General Health Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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