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

NCT ID: NCT05751382

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-01-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Restoration with Surefil one hybrid composite

In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant.

Restoration performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro).

Group Type: EXPERIMENTAL

Surefil one

Intervention Type: DEVICE

Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.

Restoration with Venus Pearl composite

In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant.

After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro).

Group Type: ACTIVE_COMPARATOR

Venus Pearl

Intervention Type: DEVICE

Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.

Interventions

Surefil one

Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.

Intervention Type: DEVICE

Venus Pearl

Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients aging from 18 to 70
• 40-60% women, 40-60% men
• Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital teeth
• Patients who are not allergic or sensitive to the ingredients contained in the products
• The test patient consents to the restorative treatment in line with the study´s criteria (informed consent)
• Sufficiently understanding of the language

Exclusion Criteria

• Extremely low level of oral hygiene
• Teeth with previous restorations
• Not possible adequate isolation of the operating area
• Patients with serious systemic diseases
• Devitalized teeth or with pulpitis in progress
• Periodontal problems on the elements to be restored

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Breschi, Prof

Role: PRINCIPAL_INVESTIGATOR

Clinica Odontoiatrica (DIBINEM)

Locations

Clinica Odontoiatrica (DIBINEM)

Bologna, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14.1535

Identifier Type: -

Identifier Source: org_study_id