Dental Caries
Conditions
Keywords
pediatric, primary molars, stainless steel crowns
Brief summary
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.
Detailed description
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.
Interventions
DEVICEZR Crown
This is an esthetic primary molar crown.
DEVICEStainless Steel Crown
This is a conventional stainless steel crown.
Sponsors
NuSmile, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Be between 3 and 7 years of age * Have a minimum of two primary molar teeth, requiring crowns * Have a parent or guardian capable of giving written informed consent * Have study teeth in occlusion and in contact with adjacent teeth * Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.
Exclusion criteria
* Tooth is considered to be within 36 months of exfoliation * They have a severe / serious childhood illness that requires frequent hospitalization * They have poor general health * They have juvenile periodontitis * Patient is unable to return for evaluations / study recalls
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessments of the SSC and ZR Crown | At Baseline | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity. |
| Assessments of the SSC and ZR Crown at 6 months | 6 month visit | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
| Assessments of the SSC and ZR Crown at 12 months | 12 month visit | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
| Assessments of the SSC and ZR Crown at 18 months | 18 month visit | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
| Assessments of the SSC and ZR Crown at 24 months | 24 month visit | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
| Assessments of SSC and ZR Crown at 36 months | 36 month visit | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
| Assessments of SSC and ZR Crowns at 48 months | 48 month visit | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. |
Countries
United States
Outcome results
None listed