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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03764059
Other study ID # MDI0102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2017
Est. completion date November 14, 2019

Study information

Verified date July 2023
Source 3M
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Description:

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Study Design


Intervention

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.
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.

Locations

Country Name City State
China Beijing Stomatology Hospital of Capital Medical University Beijing Beijing
China Peking University Hospital of Stomatology Beijing Beijing
China Hospital of Stomatology Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
3M

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Acceptance Rate of Restoration at 1 Year After Replacement According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B. 1 Year after restoration
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