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

NCT07410468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

OTHER

Group 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.

OTHER

Group 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.

OTHER

Group 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 & Collaborators

  • Marwan Abdelnaser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-02-10
Completion
2026-02-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410468 on ClinicalTrials.gov