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

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.

Study Overview

• Status: Terminated
• Conditions: Tooth Restoration
• Intervention / Treatment: Device: Surefil one; Device: Venus Pearl

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40125
    • Clinica Odontoiatrica (DIBINEM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Surefil one; Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.
Active Comparator: 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).	Device: Venus Pearl; Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Restorative Quality	The restorations will be evaluated using the World Dental Federation (FDI) criteria.	At 36 months follow-up.
Assessment of Restorative Quality	The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.	At 36 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Restorative Quality	The restorations will be evaluated using the FDI criteria.	At 6, 12 and 24 months follow-up
Assessment of Restorative Quality	The restorations will be evaluated using the USPHS criteria.	At 6, 12 and 24 months follow-up
Assessment of Aesthetics	The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.	At 6, 12, 24 and 36 months follow-up
Level of Pain	Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain.	At 6, 12, 24 and 36 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Needed to Perform the Restoration	The time needed to perform the restorations will be compared between the groups.	Day 0

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Lorenzo Breschi, Prof, Clinica Odontoiatrica (DIBINEM)

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 14.1535

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No