Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-02-15
Brief Title:
Comparative Evaluation of Bioflx Crowns vs Stainless Steel Crowns
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Comparative Evaluation of Clinical SuccessParental and Child Satisfaction of Bioflx Crowns Versus Stainless Steel Crowns as Restorations for Primary Molars A Randomized Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparative Evaluation of Clinical SuccessParental and child Satisfaction of Bioflx Crowns Versus Stainless Steel Crowns as Restorations for Primary Molars A Randomized Clinical Study
Detailed Description:
In the field of pediatric dentistry various materials can be utilized to treat decayed primary teeth such as composites glass ionomer cements or steel crowns Despite demonstrating acceptable properties numerous failures are consistently documented predominantly linked to issues like secondary caries
Over the course of time a variety of full-coverage dental restorations have been introduced and integrated into pediatric dental care Stainless-steel crowns SSCs have emerged as the most widely accepted and frequently utilized full-coverage restoration for both primary and permanent teeth in children Since the 1950s pediatric dentists globally have favored SSCs due to their exceptional durability secure cervical fit cost-effectiveness and the fact that they require minimal technique sensitivity during the restoration process
Stainless steel crowns SSCs offer robust and dependable full-coverage restorations remaining in place throughout the lifespan of a primary tooth However a notable drawback is the unfavorable metallic appearance which is disliked by both parents and children Numerous efforts have been made to develop alternative esthetic substitutes for SSCs such as composite polycarbonate thermoformed plastic and zirconia
As the emphasis on esthetics in children has grown technological progress has successfully brought about the introduction of prefabricated zirconia crowns ZCs The adoption of zirconia crowns for primary dentition began in 2008 While zirconia crowns share mechanical properties with metal they necessitate greater tooth reduction
The Bioflx crowns are characterized by their flexibility durability and adaptability These crowns are preformed pediatric crowns designed for aesthetics combining properties found in both stainless steel and zirconia crowns However there is a notable absence of scholarly evidence evaluating the properties of Bioflx crowns and their impact on clinical outcomes and parental satisfaction when compared to conventional options Consequently this study aims to examine the clinical performance of Bioflx crowns and traditional stainless steel crowns SSCs in pediatric patients with a focus on assessing child and parental satisfaction
Over the course of time a variety of full-coverage dental restorations have been introduced and integrated into pediatric dental care Stainless-steel crowns SSCs have emerged as the most widely accepted and frequently utilized full-coverage restoration for both primary and permanent teeth in children Since the 1950s pediatric dentists globally have favored SSCs due to their exceptional durability secure cervical fit cost-effectiveness and the fact that they require minimal technique sensitivity during the restoration process
Stainless steel crowns SSCs offer robust and dependable full-coverage restorations remaining in place throughout the lifespan of a primary tooth However a notable drawback is the unfavorable metallic appearance which is disliked by both parents and children Numerous efforts have been made to develop alternative esthetic substitutes for SSCs such as composite polycarbonate thermoformed plastic and zirconia
As the emphasis on esthetics in children has grown technological progress has successfully brought about the introduction of prefabricated zirconia crowns ZCs The adoption of zirconia crowns for primary dentition began in 2008 While zirconia crowns share mechanical properties with metal they necessitate greater tooth reduction
The Bioflx crowns are characterized by their flexibility durability and adaptability These crowns are preformed pediatric crowns designed for aesthetics combining properties found in both stainless steel and zirconia crowns However there is a notable absence of scholarly evidence evaluating the properties of Bioflx crowns and their impact on clinical outcomes and parental satisfaction when compared to conventional options Consequently this study aims to examine the clinical performance of Bioflx crowns and traditional stainless steel crowns SSCs in pediatric patients with a focus on assessing child and parental satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None