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

N/ACompletedNCT06120868

Nourhan M.Aly32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Class II Dental Caries

Interventions

Surefil one®OTHER

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.

Filtek OneOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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.

Time frame: up to 12 months

Data from ClinicalTrials.gov

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