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

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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Key information

Conditions

Class II Dental Caries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 One

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.

Primary outcomes

Clinical success of the restoration

Time frame: up to 12 months

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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 7, 2023
Registry last updated: Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed