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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-10

Study Completion Date

2023-09-01

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.

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Detailed Description

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Conditions

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Class II Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

a randomized controlled split-mouth study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Surefil one Self-adhesive bulk fill restorative (SABF)

Group Type EXPERIMENTAL

Surefil one®

Intervention Type 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 One Bulk Fill (FOBF)

Group Type ACTIVE_COMPARATOR

Filtek One

Intervention Type OTHER

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.

Interventions

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Surefil one®

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.

Intervention Type OTHER

Filtek One

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No