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

Not Applicable

Terminated

• Conditions: Tooth Restoration
• Interventions: Device: Surefil one; Device: Venus Pearl

• Registration Number: NCT05751382
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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.

Study Timeline

• Study Start: 2022-09-21
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Primary Completion: 2024-01-22
• Study Completion: 2024-01-22
• Results First Submitted: 2024-02-13
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Results First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Restoration with Surefil one hybrid composite	Surefil one	Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 secunds with a LED lamp (Smartlamp Pro).
Group B - Restoration with Venus Pearl composite	Venus Pearl	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).

Primary Outcome Measures

Name	Time	Method
Assessment of Restorative Quality	At 36 months follow-up	The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.

Secondary Outcome Measures

Name	Time	Method
Assessment of Restorative Quality	At 6, 12 and 24 months follow-up	The restorations will be evaluated using the USPHS criteria.
Level of Pain	At 6, 12, 24 and 36 months follow-up	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.
Assessment of Aesthetics	At 6, 12, 24 and 36 months follow-up	The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.

Trial Locations

Locations (1)

Clinica Odontoiatrica (DIBINEM); 🇮🇹 Bologna, Italy