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

Dentsply Sirona Implants and Consumables16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tooth Restoration

Interventions

Surefil oneDEVICE

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

Venus PearlDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinica Odontoiatrica (DIBINEM)

Bologna, Italy

Outcomes

Primary Outcomes

Assessment of Restorative Quality

The restorations will be evaluated using the World Dental Federation (FDI) criteria.

Time frame: At 36 months follow-up.

Assessment of Restorative Quality

The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.

Time frame: At 36 months follow-up

Secondary Outcomes

Assessment of Restorative Quality

The restorations will be evaluated using the FDI criteria.

Time frame: At 6, 12 and 24 months follow-up

Assessment of Restorative Quality

The restorations will be evaluated using the USPHS criteria.

Time frame: 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.

Time frame: 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.

Time frame: At 6, 12, 24 and 36 months follow-up

Data from ClinicalTrials.gov

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