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

NCT07410468 | Completed

• 1 other identifier: 9264203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Class II Dental Restorations

Outcome Measures

Primary Outcomes (3)

• The functional properties of the examined restorations

  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).

  1 year

• The biological properties of the examined restorations

  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).

  1 year

• The aesthetic properties of the examined restorations

  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).

  1 year

Study Arms (3)

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

ACTIVE COMPARATOR

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

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

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

Interventions

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

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

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Extensive cavitated lesions, medical compromise, and traumatic malocclusion, bruxism, or parafunctional habits.

Sponsors & Collaborators

• Marwan Abdelnaser: lead

Study Sites (1)

Faculty of dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of operative Dentistry

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)