Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Dental Caries
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique. The primary objective of this study i...

This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique. The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories: Esthetic Properties Surface luster Staining - surface Staining - margin Color match and translucency Esthetic anatomical form Functional Properties Fracture of material and retention Marginal adaptation Aproximal anatomical form - contact point Radiographic examination (when applicable) Patient's view Biological Properties Postoperative (hyper-)sensitivity and tooth vitality Recurrence of caries, erosion, abfraction Tooth integrity (enamel cracks, tooth fractures) Adjacent mucosa The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories

Tracking Information

NCT #
NCT03032705
Collaborators
Kavo Kerr Group
Investigators
Principal Investigator: Gerard Kugel, DMD, MS, PhD TUSDM