Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites

Study Overview
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Brief Summary
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This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.

Official Title
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Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)

Conditions
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Class II Dental Caries

Intervention / Treatment
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* Other: Surefil one®
* Other: Filtek One


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of restorative treatment on at least two class II Cavities in premolars or molars. Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I). Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™). Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact. Absence of parafunctional habits. Good general health Exclusion Criteria: Serious medical disorders Clinical signs of bruxism, traumatic malocclusion Pregnant or breast feeding at the time of restoration placement Intolerance or allergy toward the applied restorative materials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Sequential Assignment
Interventional Model Description: a randomized controlled split-mouth study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surefil one Self-adhesive bulk fill restorative (SABF)<br> | Other: Surefil one®<br>* For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls.<br>|
| Active Comparator: Filtek One Bulk Fill (FOBF)<br> | Other: Filtek One<br>* Scotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success of the restoration | Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced. | up to 12 months |