NCT05751382

Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs

3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin Used for Direct Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth Randomized Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.

Detailed description

The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite "Venus Pearl" employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.

Conditions

• Tooth Restoration

Interventions

Type	Name	Description
DEVICE	Surefil one	Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.
DEVICE	Venus Pearl	Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2023-03-02
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

1 site across 1 country: Italy