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Completed

NCT Number: NCT07410468

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

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

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Key information

Conditions

Class II Dental Restorations

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

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

Other

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.

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

Other

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.

Primary outcomes

  1. The functional properties of the examined restorations

    Time frame: 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).

  2. The biological properties of the examined restorations

    Time frame: 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).

  3. The aesthetic properties of the examined restorations

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Marwan Abdelnaser

Other

Registry information

Official study title

Clinical Performance of an Innovative Self-cure Bulk-Fill Composite Compared to Dual-Cure and Light-Cure Bulk-Fill Composite in Posterior Restorations (A Randomized Controlled Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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