Clinical Trial NuSmile Crowns

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

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

Study Overview

• Status: Completed
• Conditions: Primary Dental Caries, Multisurface Origin (Diagnosis)
• Intervention / Treatment: Device: Nu Smile Zirconia crown; Device: Nu Smile Pre Veneered crown; Device: Composite strip crown

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • University of Washington-The Center for Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Mariella Garcia, DDS, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2015
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Anterior primary teeth restorations
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: STUDY00003980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No