NCT04926883

Comparison Between Sonic Fill and X-tra Fill in Clinical Performance

Clinical Performance of Sonic-Activated High Viscosity Bulk-Fill Resin Composite in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth: A Randomized Controlled Clinical Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment.

Detailed description

Restorations will be evaluated 1 week after placement (Baseline - T0), 3 months (T1), 6 months (T2), 1-year (T3) and 2-years (T4) of clinical service by blinded calibrated examiner using modified United States Public Health Service (USPHS) criteria where score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced. The restorations will also be evaluated using revised FDI criteria with five grades for each criterion; scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).

Conditions

• SonicFill Clinical Performance
• Sonicated Bulk-fill Resin Composite

Interventions

Type	Name	Description
OTHER	bulk-fill composite resin restorations	bulk-fill composite resin restorations up to 5mm layer thickness

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-06-15
• Last updated: 2024-07-23

Locations

1 site across 1 country: Egypt