Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown

Conditions
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Dental Caries

Intervention / Treatment
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* Device: ZR Crown
* Device: Stainless Steel Crown


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ZR Crown & Stainless Steel Crown<br>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. | Device: ZR Crown<br>* This is an esthetic primary molar crown.<br>Device: Stainless Steel Crown<br>* This is a conventional stainless steel crown.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity. | 48 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, primary molars, stainless steel crowns