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

NCT05751382 | Terminated Results

• 1 other identifier: 14.1535
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Restoration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Assessment of Restorative Quality

  At 6, 12 and 24 months follow-up

• Assessment of Restorative Quality

  At 6, 12 and 24 months follow-up

• Assessment of Aesthetics

  At 6, 12, 24 and 36 months follow-up

• Level of Pain

  At 6, 12, 24 and 36 months follow-up

Other Outcomes (1)

• Time Needed to Perform the Restoration

  Day 0

Study Arms (2)

Restoration with Surefil one hybrid composite

EXPERIMENTAL

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

Restoration with Venus Pearl composite

ACTIVE COMPARATOR

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

Interventions

Surefil one DEVICE

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

Restoration with Surefil one hybrid composite

Venus Pearl DEVICE

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

Restoration with Venus Pearl composite

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aging from 18 to 70
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (1)

Clinica Odontoiatrica (DIBINEM)

Bologna, 40125, Italy

Location

Results Point of Contact

• Title: AnnaKarin Lungren Dr.
• Organization: Dentsply Sirona Implants and Consumables

annakarin.lundgren@dentsplysirona.com

0046 702 666 492

Study Officials

• Lorenzo Breschi, Prof

  Clinica Odontoiatrica (DIBINEM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-mouth design, i.e. each subject have both treatment arms.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 2, 2023
• Study Start: September 21, 2022
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-11

Locations

IT (1)