Clinical Trial NuSmile Crowns

Study Overview
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Brief Summary
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A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.

Detailed Description
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Stainless steel crowns have been the most common treatment for large cavities in baby teeth until recently. These crowns are silver in color, and aesthetically are not a good option for restoring front teeth. Several tooth colored options have been developed to meet the growing demand for more aesthetics on front teeth. With the variety of new options for restoring anterior primary teeth, the investigators would like to evaluate the long-term success of three tooth-colored restoration options: NuSmile Signature crowns, NuSmile ZR crowns, and composite crowns. The investigators are interested in looking at the outcomes of these three restoration types, in terms of durability, aesthetics and cost effectiveness for the treatment of front baby teeth. The purpose of this pilot study is to evaluate the clinical performance of two types of NuSmile crowns compared to composite crowns in treating large multi-surfaced cavities on front baby teeth.

Official Title
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A Clinical Trial of NuSmile's Pre-Veneered Stainless Steel Crowns and NuSmile ZR Crowns Compared With Strip Composite Crowns in Anterior Primary Teeth -- Pilot Study

Conditions
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Primary Dental Caries, Multisurface Origin (Diagnosis)

Intervention / Treatment
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* Device: Nu Smile Zirconia crown
* Device: Nu Smile Pre Veneered crown
* Device: Composite strip crown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of record at the University of Washington's Center for Pediatric Dentistry Patients in general good health (ASA I) Patients aged 5 years old or younger Patients in need of at least one preformed crowns, on anterior primary teeth Patients undergoing general anesthesia for dental treatment Parent or guardian of patient able and willing to provide informed consent Exclusion Criteria: Medically compromising condition Teeth with proximal space closures of sufficient magnitude to preclude placement of crown Teeth with complete absence of facial or lingual walls following tooth preparation Teeth that are expected to be exfoliated/extracted within one year will not participate in the study Anterior crowding Occlusion class III

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nu Smile Zirconia crown<br>Anterior primary teeth which received a NuSmile zirconia crown as a final restoration | Device: Nu Smile Zirconia crown<br>* Placement of an anterior primary crown restoration<br>|
| Active Comparator: Nu Smile pre veneered crown<br>Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration | Device: Nu Smile Pre Veneered crown<br>* Placement of an anterior primary crown restoration<br>|
| Active Comparator: Composite strip crown<br>Anterior primary teeth which received a composite strip crown as a final restoration | Device: Composite strip crown<br>* Placement of an anterior primary crown restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitting | The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention Moderate natural retention Little or no natural retention A higher score means a worse outcome | 12 months | 
| Positioning | Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position Rotated - in occlusion Not in occlusion with or without rotation A higher score means a worse outcome | 12 months | 
| Proximal Contact | The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces Floss meets little or no resistance when passes through contact Floss meets significant when passes through contact A higher score means a worse outcome | 12 months | 
| Marginal Adaptation | The number of teeth scored in the marginal adaptation categories as described below Marginal adaptation 0= No discrepancies detected with explorer Detectable discrepancies but clinically acceptable Detectable discrepancies, not acceptable -replacement required A higher score means a worse outcome | 12 months | 
| Color | The number of teeth scored in the color categories described below Color matching 0= Matches completely or within range of shade and translucency Outside range for yellow, yellow/brown discoloration or gray discoloration Outside range for reason other than yellowing or graying A higher score means a worse outcome | 12 months | 
| Gingival Status | The number of teeth scored in the gingival status categories described below Gingival status 0=Pink, firm, free of inflammation Red and/or inflamed - no bleeding on probing Spontaneous and excessive bleeding on probing A higher score means a worse outcome | 12 months | 
| Retention of the Crown | The number of teeth scored in the retention of the crown categories described below Retention of the crown 0= Intact 1= Partially missing 2 = Missing - some cement remaining on both tooth and crown interior A higher score means a worse outcome | 12 months | 
| Integrity of the Veneer/Composite | The number of teeth scored in the integrity of the veneer/composite categories described below Integrity of veneer/ composite 0= Intact Partially missing - one third missing Completely missing A higher score means a worse outcome | 12 months | 
| Secondary Caries | The number of teeth scored in the secondary caries categories described below Secondary caries 0= Absent 1= Present A higher score means a worse outcome | 12 months | 
| History of Trauma | The number of teeth scored in the history of trauma categories described below History of trauma 0= Absent 1= Present A higher score means a worse outcome | 12 months | 
| Clinical Pulp Pathology | The number of teeth scored in the clinical pulp pathology categories described below Clinical pulp pathology 0= Absent 1= Present A higher score means a worse outcome | 12 months | 
| Radiographical Pulp Pathology | The number of teeth scored in the radiographical pulp pathology categories described below Radiographical pulp pathology 0= Absent 1= Present A higher score means a worse outcome A higher score means a worse outcome | 12 months | 
| Parent's Esthetic Satisfaction | The number of teeth scored in the parent's esthetic satisfaction categories described below Parents esthetic satisfaction via a survey 0=Satisfied 1= Dissatisfied A higher score means a worse outcome | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior primary teeth restorations