Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450093
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-02
Brief Title:
Comparative Clinical Evaluation of BioFlx Zirconia and Stainless-Steel Crowns in Primary Molars
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Comparative Clinical Evaluation of BioFlx Zirconia and Stainless-Steel Crowns in Primary Molars A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This study will be conducted to
Evaluate and compare the clinical success periodontal changes and wear of antagonist teeth for three types of prefabricated crowns in primary molars BioFlx crowns Zirconia crowns and Stainless Steel crowns
Evaluate and compare the clinical success periodontal changes and wear of antagonist teeth for three types of prefabricated crowns in primary molars BioFlx crowns Zirconia crowns and Stainless Steel crowns
Detailed Description:
A randomized controlled clinical trial with three parallel groups will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration The children will be selected from the Pediatric Dental Clinic Faculty of Dentistry Mansoura University They will be randomly divided into three equal groups 17 molarseach Sequence generation and concealment will be done by a biostatistician who is not involved in the study Group I control group will include stainless steel crowns group II study group will include Zirconia crowns group III study group will include BioFlx crowns After obtaining the written consent form from the parents or guardians the children will be randomly enrolled and teeth will be assigned to the groups to receive the selected crowns Clinical evaluation will be done concerning crown retention color stability secondary caries periodontal changes and wear of the opposing natural enamel All crowns will be evaluated at the 3rd 6th 12th and 18th months
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