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

Not Applicable

Completed

• Conditions: Primary Teeth
• Interventions: Other: Direct composite restoration of carious primary anterior teeth using custom 3D printed templates; Other: Direct composite restoration of carious primary anterior teeth using conventional strip crowns

• Registration Number: NCT06478004
• Lead Sponsor: Minia University

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 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).

Study Timeline

• Study Start: 2023-02-15
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-15
• Status Verified: 2024-06
• Study First Submitted: 2024-06-15
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Presence of at least two vital carious primary maxillary incisors.
• Teeth had at least two carious surfaces requiring complete coronal restoration.

Exclusion Criteria

• Children with malocclusion or parafunctional oral habits
• Teeth beyond restoration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct resin composite with the help of custom 3D printed templates	Direct composite restoration of carious primary anterior teeth using custom 3D printed templates	Directly restoring carious primary anterior teeth with resin composite with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models.
Direct resin composite using conventional strip crowns.	Direct composite restoration of carious primary anterior teeth using conventional strip crowns	Directly restoring carious primary anterior teeth with resin composite using conventional strip crowns.

Primary Outcome Measures

Name	Time	Method
Surface luster	On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)	Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Anatomical form	On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)	Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Material fracture	On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)	Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Marginal adaptation	On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)	Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Periodontal response	On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)	Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

Trial Locations

Locations (1)

Faculty of Dentistry, Minia University; 🇪🇬 Minya, Egypt