Clinical Performance of an Innovative Self-cure Bulk-Fill Composite Compared to Dual-Cure and Light-Cure Bulk-Fill Composite in Posterior Restorations.

Marwan Abdelnaser

Status: Completed

Conditions: Class II Dental Restorations

Treatments: Other: Group III (n=20): were restored with light-cure bulk-fill.; Other: Group II (n=20): were restored with dual-cure bulk-fill.; Other: Group I (n=20): were restored with self-cure bulk-fill.

Study type: Interventional

Funder types: Other

Identifiers

NCT07410468

9264203

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Group II: dual-cure bulk-fill (Fill-up) with ParaBond adhesive system

Active Comparator group

Treatment:

Other: Group II (n=20): were restored with dual-cure bulk-fill.

Group III: light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive.

Active Comparator group

Treatment:

Other: Group III (n=20): were restored with light-cure bulk-fill.

Group I: self-cure bulk-fill (Stela capsules) with Stela primer

Active Comparator group

Treatment:

Other: Group I (n=20): were restored with self-cure bulk-fill.