Class II Dental Restorations
Conditions
Brief summary
This clinical trial aimed to compare the 1-year clinical performance of a self-cure bulk fill (Stela Capsules), a dual-cure bulk fill (Fill-Up), and a light-cure bulk fill (Tetric N-ceram bulk fill) in class II dental composite restorations
Detailed description
A total of 60 direct class II restorations were divided into three groups: Group I (n=20): were restored with self-cure bulk-fill (Stela capsules) with Stela primer; Group II (n=20): were restored with dual-cure bulk-fill (Fill-up) with ParaBond adhesive system; Group III (n=20): were restored with light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive. Each material was applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \< 0.05.
Interventions
OTHERGroup I (n=20): were restored with self-cure bulk-fill.
A total of 60 direct class II restorations were divided into three groups: Group I (n=20): were restored with self-cure bulk-fill (Stela capsules) with Stela primer applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \< 0.05.
OTHERGroup II (n=20): were restored with dual-cure bulk-fill.
A total of 60 direct class II restorations were divided into three groups: Group II (n=20): were restored with dual-cure bulk-fill (Fill-up) with ParaBond adhesive system applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \< 0.05.
OTHERGroup III (n=20): were restored with light-cure bulk-fill.
A total of 60 direct class II restorations were divided into three groups: Group III (n=20): were restored with light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive. Each material was applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \< 0.05.
Sponsors
Marwan Abdelnaser
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* The presence of proximal caries on posterior teeth in a digital x-ray with a score of 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS). * The antagonist and the adjacent tooth make contact. * The teeth should have no signs of pulpitis. * Patients with no periodontal disease * No major systemic disorders or allergies
Exclusion criteria
\- Extensive cavitated lesions, medical compromise, and traumatic malocclusion, bruxism, or parafunctional habits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The functional properties of the examined restorations | 1 year | All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Functional properties: (F1) Fracture of material and retention. (F2) Marginal adaptation. (F3) Proximal contact point. (F4) Form and contour. (F5) Occlusion and wear. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), score 3: Clinically satisfactory (CS), score 4: Clinically unsatisfactory (CU), score 5: Clinically poor (PO). |
| The biological properties of the examined restorations | 1 year | All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the revised FDI evaluation criteria and scoring system, which indicates: Biological properties (B1) Caries at restoration margins. (B2) Dental hard tissue defects at the restoration margin. (B3) Postoperative hypersensitivity and pulpal status. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO). |
| The aesthetic properties of the examined restorations | 1 year | All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Aesthetic properties: (A1) Surface luster and surface texture. (A2) Marginal staining. (A3) Color match. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO). |
Countries
Egypt
Outcome results
None listed