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临床试验/NCT04475172
NCT04475172Unknown不适用

Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Marginal integrity of Class V restorations

研究概览

简要总结

This clinical trial will be conducted to compare the clinical performance of a new self-adhering flowable composite in restoring CLs compared to conventional flowable composite in geriatric patients over 12 months.

详细描述

Recently, self-adhesive flowable composites (SAFCs) have been introduced as a new class of restorative material in adhesive dentistry. Today, there are only two available products in the market for clinical use: Vertise Flow and Fusio Liquid Dentin. Self-adhering flowable composite was introduced to address the time-consuming procedure used with traditional materials Their resin matrix contains acidic functional adhesive monomers mediating bonding with dental hard tissues and, therefore, separate etching and additional bonding are not required. SAFCs have been mainly advertised for the restoration of small Class I, Class III and V cavities, for cavity lining, and for use as a pit and fissure sealant.

Self-adhering flowable composite combines the merits of both adhesive and restorative material technologies in one product, bringing novel horizons to restorative techniques, as it is a direct composite resin restorative material that has an adhesive resin together with a flowable composite resin. It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin. This resin bonds chemically between the phosphate groups of a GPDM monomer and the hydroxyapatite of tooth structure and, also, micromechanically between the polymerized monomers of the self-adhering flowable composite resin and the collagen fibers and smear layer of dentin.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Quadruple

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Cervical Class V carious lesions in anterior and premolars teeth.
  • •Age above 60 years.
  • •Males and females.

排除标准

  • •• patient less than 60 years with disabilities, systemic disease, severe medical conditions, rampant caries, and xerostomia.
  • •In addition, teeth with potential prosthodontics restoration and nonvital or endodontically treated teeth.

研究组 & 干预措施

Fusio™ Flowable Self-Adhesive Flowable Composite

Experimental

2-Cavity preparation steps:

  • patients will be given local anesthesia as required,the operative field will be isolated with rubber dam before starting.
  • Conventional design Class V cavity will be prepared on the buccal surface of tooth by No. #330 bur (0.8 mm in diameter and 1.6 mm in length) , tooth surfaces will be kept moist to protect them against dehydration.
  • 2% chlorhexidine gluconate disinfecting solution .
  • wash the dentin surface with water spray and air dry with maximum air pressure for 5 s.

A) Intervention: Fusio™ Flowable (Self adhesive flowable composite):

  • Simply syringe into the preparation 1 mm increments, agitate with tip or brush for 20 s, and light-cure.No need for an etchant or an adhesive.

干预措施: Self-Adhesive Flowable Composite (Combination Product)

Conventional flowable composite [Tetric Evo Flow (FF)].

Active Comparator

Tetric Evo Flow (Conventional flowable composite):

  • After cleaning cavities, apply conditioning material (phosphoric acid etching 37% ) and apply bonding agent (ExciTE® F) according to the instructions for use of the product.
  • Apply Tetric EvoFlow in layers of 1mm. Polymerize each layer separately following the instructions for use of this product. . Hold the light emission window as closely as possible to the surface of the restorative material.

All 20 Class V restorations will be prepared, restored, finished, and polished by one operator. Each of the 10 patients had one (FL) restoration and the other restoration will be filled with (FF).

干预措施: Self-Adhesive Flowable Composite (Combination Product)

结局指标

主要结局

Marginal integrity of Class V restorations

时间窗: Clinical Evaluation of Marginal integrity after 6 months after starting treatment.

clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta

次要结局

  • Postoperative sensitivity(at baseline and 3 months after starting treatment .)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatheya Mansour Atifa Elshnawy

principal investigator

Cairo University

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