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

NCT03764059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-07-21

Study results available
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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.

Conditions

  • Dental Caries Class I
  • Dental Caries Class II

Interventions

DEVICE

Filtek™ Bulk Fill Posterior Restorative

The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.

DEVICE

Filtek™ Z350XT Universal Restorative

The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.

Sponsors & Collaborators

  • 3M

    lead INDUSTRY

Principal Investigators

  • Xiaoyan Wang, Director · Endodontics department of Peking University hospital of stomatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2019-11-14
Completion
2019-11-14
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764059 on ClinicalTrials.gov