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临床试验/NCT06205420
NCT06205420已完成4 期

Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children A Randomized Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
14
试验地点
1
主要终点
Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations.

研究概览

简要总结

This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Follow up will be done every 6 months for 2 years.

详细描述

The aim of this study is to evaluate and compare the two-year clinical performance of injectable giomer restoration to an injectable composite resin restoration using the injection molding technique for veneering permanent maxillary and mandibular anterior teeth affected with enamel hypoplasia in children using the FDI criteria.

Injection molding technique using injectable composite resin restoration and injectable giomer restoration will be implemented for the esthetic management of permanent anterior teeth affected with enamel hypoplasia in children after removal of the defective enamel, its etching and bonding. Evaluation of their performance will be done using FDI criteria and will be followed up for 2 years.

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)

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy patients: Class I according to the American Society of Anaesthesiologists (ASA class I).
  • Teeth scored code 3 according to Modified Developmental Defects of enamel (mDDE) index.
  • Maxillary and mandibular permanent anterior teeth

排除标准

  • Refusal of the parents to sign the informed consent.
  • Signs and symptoms of reversible or irreversible pulpitis, as well as necrosis affecting the permanent anterior teeth.
  • Enamel hypomineralization

研究组 & 干预措施

Injectable composite resin restoration

Experimental

The use of injectable GC Gaenial restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria.

干预措施: Injectable composite resin restoration (Drug)

Injectable Giomer restoration

Experimental

The use injectable beautiful flow giomer restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria.

干预措施: Injectable giomer restoration (Drug)

Control: Direct Composite Resin Laminate

Active Comparator

Direct composite resin laminate will be placed by direct layering on anterior teeth affected with enamel hypoplasia and evaluated for its clinical performance by the FDI criteria.

干预措施: Active comparator: Direct composite resin laminate (Drug)

结局指标

主要结局

Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations.

时间窗: every 6months for 2 years

Clinical performance of an injectable giomer compared to composite restoration in permanent anterior teeth with enamel hypoplasia evaluated by FDI criteria to assess the quality of direct restorations. These are divided into functional, biological, esthetic, and miscellaneous properties. The functional properties assess the fracture of material, its retention, the marginal adaptation, the proximal contact point, the form and contour, the occlusion and wear of dental restorations. The biological assess the presence of recurrent caries, the hard dental tissue defect at the restoration margin, postoperative hypersensitivity and pulpal status, while the esthetic evaluates surface luster and texture, marginal staining, and color match. The miscellaneous examines the patient's perspective of the restoration and the radiographic appearance of the restorations. Every domain assessed is given a score from 1-5, where 1 indicates a clinically excellent property and 5 a clinically poor property.

次要结局

  • The Mean Annual Failure rate using the World Dental Federation (FDI) criteria.(1 year)
  • Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives(6 months)

研究者

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

Nour Wahba

Lecturer of Pediatric Dentistry

Ain Shams University

研究点 (1)

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