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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filtek One | Active Comparator | Bulk fill composite material used for posterior tooth fillings. |
|
| Filtek Z250 | Active Comparator | Composite material used for incremental filling of posterior teeth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filtek One | Device | Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Confirmation of material safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde C Peters, DMD, PhD | LSUHSC School of Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lousiana State University Health Science Center, School of DentistrySchool of Dentistry | New Orleans | Louisiana | 70119 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 3, 2023 | Oct 27, 2023 | 5 |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D009057 | Stomatognathic Diseases |
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In a split-mouth design, each participant will receive 2 matched restorations, one of each material.
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Double blind (Subject, Investigator, Outcomes Assessor)
| Filtek Z250 | Device | Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique. |
|
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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 |