跳至主要内容
临床试验/NCT06890949
NCT06890949尚未招募不适用

Evaluation of Occlusal Wear of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Occlusal wear of crown

研究概览

简要总结

The goal of this clinical trial is to evaluate the occlusal wear of Bioflx crowns compared to zirconia crowns in the restoration of primary molars.

The main question[s] it aims to answer : " Is there a difference in the occlusal wear of BioFlx crowns compared to zirconia crowns in the restoration of primary molars?" The study will also assess the clinical performance of both types of crowns in terms of retention,gingival health, preparation time, as well as child and parental satisfaction.

详细描述

Occlusal wear is a critical factor in determining the longevity and functional efficiency of dental restorations, especially in pediatric patients. Primary molars undergo significant masticatory forces, which can lead to material wear and affect the restoration's durability. Bioflex (a relatively new material) and zirconia crowns are commonly used for full-coverage restorations in primary molars, yet there is limited research comparing their occlusal wear characteristics. Understanding how these materials perform under occlusal forces can guide clinicians in selecting the most suitable material for pediatric dental restorations Dental caries in primary molars represent a significant issue within pediatric dentistry. In cases where traditional fillings prove insufficient, full coronal coverage becomes necessary. Stainless steel crowns (SSCs) have long been the standard due to their durability and cost-effectiveness, but their metallic appearance has led to increased interest in aesthetic alternatives like zirconia and Bioflx crowns.

Zirconia offers improved aesthetics, biocompatibility, and mechanical strength, though its long-term clinical performance remains underexplored. While zirconia crowns provide durability and superior aesthetics, they require significant tooth preparation, which may compromise tooth structure. Bioflx crowns, a newer option, combine the benefits of stainless steel and zirconia with more flexibility and less tooth reduction. However, comparative studies on their clinical efficacy, occlusal wear, and patient satisfaction are still needed.

Zirconia offers improved biocompatibility, mechanical strength, and enhanced esthetics, but limited comparative data exists regarding its clinical performance.

The growing awareness among parents regarding the importance of maintaining primary teeth until their natural shedding necessitates a thorough evaluation of the durability, wear resistance, retention, gingival response, and overall clinical efficacy of these crown materials. Zirconia crowns have been the preferred choice for aesthetic restorations due to their natural appearance and durability. However, their requirement for excessive tooth preparation poses challenges in pediatric patients.

Bioflx crowns, made from a biocompatible hybrid resin polymer, offer a flexible fit with minimal tooth reduction while maintaining aesthetic appeal. A comprehensive comparison of occlusal wear between these two materials is crucial for assisting clinicians in selecting the most suitable restorative solution for primary molars. This research seeks to offer evidence-based guidance by evaluating the long-term clinical performance of Bioflx crowns in relation to zirconia crowns.

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
Single (Participant)

盲法说明

statistician

入排标准

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

入选标准

  • •Children aged between 4 and 8 years with primary molar that needs to be covered by crown.
  • •Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
  • •Children whose parent or guardian are willing to sign an informed consent.
  • •Children whose parent or guardian are willing to comply with follow-up visits. -
  • •Frankl's positive and definitely positive patient

排除标准

  • •Molars with severe structural loss that may compromise crown retention.
  • •Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
  • •Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns.
  • •Children with any systemic conditions or disabilities that may affect their ability to participate in the study.

研究组 & 干预措施

(Group A : preformed Bioflx crown

Experimental

Kids-e-Dental LLP (ANDHERI, MUMBAI, INDIA) introduced Bioflx Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Bioflx Crowns are monochromatic, metal-free, tooth-colored crowns made up of high- strength resin polymer used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are like SSC in tooth preparation as claimed by the manufacturer. Their flexibility and snap-fit technology aim to improve retention while minimizing trauma during placement

干预措施: (Group A: Preformed Bioflx Crown) (Other)

(Group B: Preformed zirconia crown)

Experimental

NuSmile Zirconia Crowns are prefabricated, esthetic full-coverage restorations designed for primary teeth. Known for their superior strength, durability, and natural tooth-like appearance, these crowns provide an excellent alternative to traditional stainless steel crowns. Made from high-quality medical-grade zirconia, they are biocompatible, resistant to chipping, and highly polished to minimize plaque accumulation and gingival irritation.

NuSmile Zirconia Crowns require significant tooth preparation for proper fit and retention. They are available in various sizes to accommodate different primary molars and anterior teeth. Their lifelike translucency and color-matching capabilities make them a preferred choice for parents and clinicians seeking a highly esthetic and long-lasting pediatric restoration

干预措施: (Group B: Preformed Zirconia crown) (Other)

结局指标

主要结局

Occlusal wear of crown

时间窗: T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month]

Measure by Modified United States Public Health System criteria: Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure Charlie: Wear of occlusal surface with exposure

次要结局

  • Retention([Time Frame: follow-up:T (Time): 12months interval T0: 0 T1: 3month T2: 6month T3 : 12 month])
  • Gingival Health(T (Time): 12 months interval T0: 0 T1: 3month T2: 6month T3 : 12 month])
  • preparation time([Time Frame: baseline])
  • child and parental satisfaction([Time Frame: T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month])

研究者

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

Eithar Musa Abdelrahman Hussien

Principal investigator

Cairo University

研究点 (1)

Loading locations...

相似试验