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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03175627
Other study ID # 11-050008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2017
Est. completion date May 31, 2021

Study information

Verified date June 2021
Source Louisiana State University Health Sciences Center in New Orleans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.


Description:

In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - be older than 18 years of age - have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings - both study teeth must be vital (tested with cold) - both study fillings must be visible on the cheek-side of the tooth. Exclusion Criteria: - do not meet all inclusion criteria - are under active orthodontic treatment - have severe medical complications - have dry mouth - have chronic gum disease or poor oral hygiene - are unavailable for long term recall (minimum of 2 years required) - cannot tolerate the rubber dam - have an unstable tooth contacts - have severe bruxing or clenching, or are in need of jaw joint therapy - are pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Filtek One
Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
Filtek Z250
Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.

Locations

Country Name City State
United States Lousiana State University Health Science Center, School of DentistrySchool of Dentistry New Orleans Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Louisiana State University Health Sciences Center in New Orleans 3M

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with restoration failure of either material Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure. 2 years
Secondary Clinical performance score for each restoration Quality rating for each restoration/material based on the FDI clinical performance scores (1-5) for the three categories esthetic, functional and biological performance. 2 years
Secondary Confirmation of material safety Number of participants with unanticipated treatment-related Adverse Events as assessed by • Fatal, • Persistent disability or significant incapacity, • Congenital anomaly/birth defect or cancer, • Life-Threatening, • Associated with overdose, • Required hospital admission or prolongation of hospitalization (Adverse Events Reporting Requirements LSUHSC-NO IRB). 2 years
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