Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478004
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-15
Brief Title:
Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates A 12-Month Parallel Randomized Controlled Clinical Trial
Status:
COMPLETED
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:
RCT
Brief Summary:
Esthetic restoration of primary anterior teeth is challenging Aim of the study Evaluation of the 12-month clinical performance of direct resin composite restoration of carious vital primary anterior teeth using custom 3D printed templates compared to conventional strip crowns Subjects and methods A parallel arms randomized controlled clinical trial was performed in which 98 carious vital primary anterior teeth in 32 children were directly restored with resin composite either with the help of custom 3D printed templates Group A or strip crowns Group B Restorations were assessed for surface luster anatomical form material fracture marginal adaptation and periodontal response using the revised FDI criteria on three occasions a week after placement T0 after six months T1 and after twelve months T2 Comparisons between groups were evaluated A statistically significant level was considered when p value less than or equal 005 The tooth was the unit of analysis
Detailed Description:
The present study is a single-center randomized controlled clinical trial with 11 allocation ratio This trial entailed directly restoring carious primary anterior teeth with resin composite either with the help of custom 3D printed templates obtained from digitally waxed-up patients dental models Group A or conventional strip crowns Group B Restorations were assessed for clinical performance on three occasions postoperatively T0 after six months T1 and after twelve months T2
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?:
False
Is an FDA AA801 Violation?:
None