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| Name | Class |
|---|---|
| 3M Oral Care | OTHER |
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The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.
In this post-market longitudinal prospective randomized control clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the efficacy of two high-strength glass ionomer restorative materials for a period of up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketac Universal | Active Comparator | Simplified glass ionomer tooth filling |
|
| Ketac Molar Quick | Active Comparator | Glass ionomer tooth filling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketac Universal | Device | High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration survival | Survival based on criteria for posterior glass ionomer restorations | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance of restoration and restored tooth | Clinical performance based on criteria for posterior glass ionomer restorations | 3 years |
| Additional Collection of Adverse Events Data | Data collection of adverse events |
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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 Dentistry | New Orleans | Louisiana | 70119 | United States |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D009057 | Stomatognathic Diseases |
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| Ketac Molar Quick | Device | High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step. |
|
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| 3 years |