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Clinical Trial Summary

The purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities. In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.


Clinical Trial 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 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 - Approximate anatomical form - contact point - Radio-graphic 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03032705
Study type Interventional
Source Tufts University
Contact
Status Completed
Phase N/A
Start date June 19, 2017
Completion date February 5, 2020

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