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

Dentsply

Status: Terminated

Conditions: Tooth Restoration

Treatments: Device: Surefil one; Device: Venus Pearl

Study type: Interventional

Funder types: Industry

Identifiers

NCT05751382

14.1535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Restoration with Surefil one hybrid composite

Experimental group

Description:

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).

Treatment:

Device: Surefil one

Restoration with Venus Pearl composite

Active Comparator group

Description:

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).

Treatment:

Device: Venus Pearl