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临床试验/NCT06897020
NCT06897020尚未招募不适用

Evaluation of Child and Parental Satisfaction 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1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
Child and Parents Satisfaction

研究概览

简要总结

The goal of this clinical trial is to evaluate the child and parents satisfaction 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 child and parents satisfaction levels between BioFlx crowns and 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, occlusal wear, gingival health, as well as preparation time.

详细描述

The management of severely decayed primary teeth in pediatric dentistry often requires the use of crowns to restore function and aesthetics. Traditional stainless-steel crowns (SSCs) have been widely used due to their durability and cost-effectiveness; however, their metallic appearance and lack of aesthetic appeal have prompted the development of alternative materials such as zirconia and Bioflx crown. Zirconia crowns are recognized for their superior aesthetics and biocompatibility, making them a preferred choice for parents who prioritize appearance. However, they can present challenges in terms of retention, preparation requirements, and cost. Bioflx crowns, a newer material in pediatric dentistry, aim to combine aesthetic appeal with flexibility and improved adaptability to tooth anatomy. Despite their growing popularity, limited research directly compares the child and parental satisfaction between zirconia and Bioflx crowns. It remains unclear which material offers the best balance of functional, aesthetic, and patient-centered outcomes.This gap in knowledge hinders evidence-based decision-making when selecting crowns for pediatric patients. Zirconia crowns have gained prominence in pediatric dentistry as an alternative to stainless steel crowns for primary molars. While SSCs have long been valued for their durability and ease of placement, their metallic appearance often presents an aesthetic concern for parents and patients. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority. One of the main advantages of zirconia crowns is their biocompatibility, as they demonstrate lower plaque accumulation and gingival inflammation. Additionally, zirconia crowns offer superior mechanical properties, including high flexural strength and excellent fracture resistance, making them a long-lasting restorative option. Their wear resistance further supports their use in pediatric patients, particularly those with heavy occlusal forces. This study stems from the need to bridge the gap in current research regarding the satisfaction and the effectiveness associated with Bioflx crowns. Understanding whether Bioflx crowns offer superior aesthetic and functional outcomes compared to Zirconia crowns could influence clinical decision-making in pediatric dentistry. This is especially relevant as parents increasingly seek restorations that provide both durability and a natural appearance for their children.

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)

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

  • •The Inclusion criteria:
  • •Children aged four to eight years old who are appearing healthy and free of any systemic disease according to parental history.
  • •Frankl's positive and definitely positive children.
  • •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.
  • •Primary molars indicated for crowns. •

排除标准

  • •Children with
  • •Exclusion Criteria:
  • •The Exclusion criteria:
  • •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.
  • •Child with parafunctional habits.
  • •Molars with severe structural loss that may compromise crown retention.
  • •Presence of malocclusion such as crossbite or scissor bite.
  • •Primary molar with root caries.
  • •Primary molar with root resorption or furcation involvement.

研究组 & 干预措施

(Group A: Performed Bioflx crowns)

Experimental

Bioflx Crowns, claimed to be the first flexible, durable, and aesthetic preformed crowns for primary molars. Bioflx are monochromatic, metal-free, tooth-colored crowns made from a high-strength resin polymer used in the medical device industry, offering strength, flexibility, and durability.These crowns are autoclavable and are claimed to require similar tooth preparation as SSCs.

干预措施: (Group A: Bioflx crowns) (Other)

(Group B: Preformed zirconia crown)

Experimental

Zirconia crowns brought a concept shift in esthetics of crowns; they are the most esthetic option available for treating primary molars. These crowns are resilient, tooth-colored, and highly polished. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority.

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

结局指标

主要结局

Child and Parents Satisfaction

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

Method of Measurement: * 5-Point likert's scale unites of measurement: 1. Very Happy. 2. Happy. 3. Neither. 4. Unhappy. 5. Very Unhappy. * Questionnaire:Ordinary or N/A existing validated tool.

次要结局

  • Retention([Time Frame: follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month])
  • Occlusal wear of crown([Time Frame: T (Time): 6months interval T0: 0 T1: 3 month T2: 6month])
  • Gingival health([Time Frame: T (Time): 6months interval T0: 0 T1: 3month T2: 6month])
  • Preparation time([Time Frame: baseline])

研究者

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

Razan Adil Yousif Ahmed

Principal Investigator

Cairo University

研究点 (1)

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