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

Dental Caries Class II Clinical Trial

Official title: A Randomized Multicenter Two-Arm Clinical Study to Evaluate the Safety and Efficacy of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations

Status Completed

Clinical Trial Summary

Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and II dental cavities in posterior teeth.

Clinical Trial Description

This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical performance of resin composite, Filtek™ Bulk Fill.

Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market for 5 years with some validated clinical data.

Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into the study and were randomly assigned to the test group and the control group according to the ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240 subjects were randomly enrolled in the study, including 120 subjects in the test group and 120 subjects in the control group, which met the required sample size.

The study consisted of screening period (initial screening visit, post-preparation screening visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests required in the protocol would be conducted to select the subjects meeting the criteria for inclusion. The examination and evaluation of the initial screening period were supposed to be completed within 0.5 days. Then investigators would make an appointment with the subjects eligible for the initial screening for cavity preparation and tooth filling, the required time of which depended on the complexity of the tooth problem and would be completed within 0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were selected and qualified after preparation and patients with qualified score would continue to have the 1-week and 1-year follow-up visits.

Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the corresponding test product or control product to fill and restore posterior teeth defects (class I or class II cavities).

Since all investigators were required to operate according to instructions, it was clear to them which product a subject was given. However, subjects and clinical evaluators were blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the control product (Filtek™ Z350XT) was used by the subjects.

Immediately after restoration placement, at 1 week and 1 year postoperative, two or three clinical evaluators from each site performed the clinical assessment (the third more senior evaluator performed the assessment and determination if the first two evaluators were not in agreement) per China Technical Instruction and Guidance of Resin Composite Restoration Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical acceptable rate of the restoration at 1 year was the primary endpoint in this study.

AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment result, if the clinical acceptance rate of the two groups achieved the clinical acceptable rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1 and II restorations. ;

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class I
• Dental Caries Class II

• NCT number: NCT03764059
• Study type: Interventional
• Source: 3M
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Completion date: November 14, 2019