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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct resin composite with the help of custom 3D printed templates | Experimental | 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. |
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| Direct resin composite using conventional strip crowns. | Active Comparator | Directly restoring carious primary anterior teeth with resin composite using conventional strip crowns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct composite restoration of carious primary anterior teeth using custom 3D printed templates | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mina Yassa, Doctor | Faculty of Dentistry, Minia University, Minia, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Minia University | Minya | Egypt |
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Single-center, prospective randomized controlled clinical trial
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| Direct composite restoration of carious primary anterior teeth using conventional strip crowns | Other | Direct composite resin restoration using celluloid crown forms |
|
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) |