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

Sponsor

Nourhan M.Aly (Other)

Overall Status

Completed

CT.gov ID

NCT06120868

Collaborator

(none)

Enrollment

Location

Arms

13.7

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Class II Dental Caries	Other: Surefil one® Other: Filtek One	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

a randomized controlled split-mouth study.a randomized controlled split-mouth study.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 10, 2022

Actual Primary Completion Date :

Sep 1, 2023

Actual Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surefil one Self-adhesive bulk fill restorative (SABF)	Other: 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.
Active Comparator: Filtek One Bulk Fill (FOBF)	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.

Arm

Intervention/Treatment

Experimental: Surefil one Self-adhesive bulk fill restorative (SABF)

Other: 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.

Active Comparator: Filtek One Bulk Fill (FOBF)

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.

Outcome Measures

Primary Outcome Measures

Clinical success of the restoration [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21512

Sponsors and Collaborators

Nourhan M.Aly

Investigators

Principal Investigator: Mohamed S Ellithy, BDS, Alexandria University
Study Director: Rania R Afifi, PhD, Alexandria University
Study Chair: Mohamed H Hussein, PhD, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria

ClinicalTrials.gov Identifier:

NCT06120868

Other Study ID Numbers:

7/2022

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Nov 7, 2023