Last updated on February 2019

Clinical Study of Filtek Bulk Fill Posterior Restorative in Class I and II Restorations

Brief description of study

This study evaluate the safety and efficacy of Filtek Bulk Fill in Class I and II restorations at 1 week and 1 year postoperative; 3 hospitals in China participated and 240 subjects will be enrolled, half of subjects will receive Filtek bulk full posterior restoration and the other half will receive Z350XT as control.

Detailed Study Description

This is a randomized, two- arm, non-inferiority study to evaluate the safety and clinical performance of resin composite. 240 qualified subjects will be enrolled. Filtek Z350XT Universal Restorative (Z350 XT) will serve as the control in this study. The subjects will be assigned to either the investigational product (Filtek Bulk ) or the control product (Z350XT) per web-based randomization system by statisticians for class I or II restoration.

Immediately after restoration placement, at 1 week and 1 year postoperative, two evaluators from each site will perform an independent clinical assessment. The clinical acceptable rate of the restoration at 1 year is the primary endpoint in this study. Two or three clinical evaluators from each site will perform the clinical assessment (the third more senior evaluator will perform the assessment and determination if the first two evaluators are not in agreement) per China Technical Instruction and Guidance of Resin Composite Restoration Material For CFDA Registration (Technical Instruction and Guidance in short) (please refer to Table 1). AE/SAE will be collected to evaluate the safety of Filtek Bulk. Based on the assessment result, if the clinical acceptance rate of the two groups achieves the clinical acceptable rate defined in the protocol, it indicates that Filtek Bulk is efficacious for class 1 and II restorations.

Clinical Study Identifier: NCT03764059

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