NCT06478004

Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates

Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates: A 12-Month Parallel Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

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 0.05. The tooth was the unit of analysis.

Detailed description

The present study is a single-center randomized controlled clinical trial with 1:1 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).

Conditions

• Primary Teeth

Interventions

Type	Name	Description
OTHER	Direct composite restoration of carious primary anterior teeth using custom 3D printed templates	A patient dental model is acquired by digital scan then digital waxing-up is performed using the Exocad software to 3D print clear templates for direct composite resin restoration.
OTHER	Direct composite restoration of carious primary anterior teeth using conventional strip crowns	Direct composite resin restoration using celluloid crown forms

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-04-01
• Completion: 2024-04-15
• First posted: 2024-06-27
• Last updated: 2024-07-01

Locations

1 site across 1 country: Egypt