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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tooth Restoration

Intervention / Treatment
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* Device: Surefil one
* Device: Venus Pearl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth design, i.e. each subject have both treatment arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Restoration with Surefil one hybrid composite<br>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). | Device: Surefil one<br>* Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.<br>|
| Active Comparator: Group B - Restoration with Venus Pearl composite<br>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<br>* Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of restorative quality | The restorations will be evaluated using the FDI criteria. | At 36 months follow-up | 
| Assessment of restorative quality | The restorations will be evaluated using the 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 |