Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates
NCT Number: NCT06478004
Acronym: RCT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
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
Sponsor: Minia University
Sex: ALL
Age: CHILD
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-15
Completion Date: 2024-04-15
Locations: Faculty of Dentistry, Minia University, Minya, Egypt

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.

Primary Outcome Measures: Surface luster, 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), On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)|Anatomical form, 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), On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)|Material fracture, 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), On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)|Marginal adaptation, 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), On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)|Periodontal response, 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), On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)