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

NCT05751382 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-01-13

Study results available
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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.

Conditions

  • Tooth Restoration

Interventions

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.

Sponsors & Collaborators

  • Dentsply Sirona Implants and Consumables

    lead INDUSTRY

Principal Investigators

  • Lorenzo Breschi, Prof · Clinica Odontoiatrica (DIBINEM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-01-22
Completion
2024-01-22

Countries

  • Italy

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 NCT05751382 on ClinicalTrials.gov