Primary Teeth
Conditions
Keywords
Early childhood caries, Strip Crown, 3D Printing
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).
Interventions
OTHERDirect 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.
OTHERDirect composite restoration of carious primary anterior teeth using conventional strip crowns
Direct composite resin restoration using celluloid crown forms
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single-center, prospective randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed