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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Assessment of Restorative Quality
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Restoration with Surefil one hybrid composite
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).
Intervention: Surefil one (Device)
Restoration with Venus Pearl composite
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).
Intervention: Venus Pearl (Device)
Outcomes
Primary Outcomes
Assessment of Restorative Quality
Time Frame: At 36 months follow-up
The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.
Assessment of Restorative Quality
Time Frame: At 36 months follow-up.
The restorations will be evaluated using the World Dental Federation (FDI) criteria.
Secondary Outcomes
- Assessment of Restorative Quality(At 6, 12 and 24 months follow-up)
- Level of Pain(At 6, 12, 24 and 36 months follow-up)
- Assessment of Aesthetics(At 6, 12, 24 and 36 months follow-up)