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The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.
The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZR Crown & Stainless Steel Crown | Other | Each subject will have a maximum of one ZR Crown and one Stainless Steel Crown cemented on primary molars that are treatment planned for a crown. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZR Crown | Device | This is an esthetic primary molar crown. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessments of the SSC and ZR Crown | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity. | At Baseline |
| Assessments of the SSC and ZR Crown at 6 months | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. | 6 month visit |
| Assessments of the SSC and ZR Crown at 12 months | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. | 12 month visit |
| Assessments of the SSC and ZR Crown at 18 months | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. | 18 month visit |
| Assessments of the SSC and ZR Crown at 24 months | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. | 24 month visit |
| Assessments of SSC and ZR Crown at 36 months | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. | 36 month visit |
| Assessments of SSC and ZR Crowns at 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin J. Donly, D.D.S., M.S. | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center-Dental School | San Antonio | Texas | 78229 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14121956 | Background | LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available. | |
| 6935165 | Background | Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Stainless Steel Crown |
| Device |
This is a conventional stainless steel crown. |
|
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
| 48 month visit |
| The University of Texas Health Science Center-Ricardo Salinas Dental Clinic |
| San Antonio |
| Texas |
| 78237 |
| United States |