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

Not Applicable

Completed

• Conditions: Class II Dental Caries
• Interventions: Other: Filtek One; Other: Surefil one®

• Registration Number: NCT06120868
• Lead Sponsor: Nourhan M.Aly

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-10
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Filtek One Bulk Fill (FOBF)	Filtek One	-
Surefil one Self-adhesive bulk fill restorative (SABF)	Surefil one®	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt