Clinical Trial NuSmile Crowns

University of Washington97 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Dental Caries, Multisurface Origin (Diagnosis)

Interventions

Nu Smile Zirconia crownDEVICE

Placement of an anterior primary crown restoration

Nu Smile Pre Veneered crownDEVICE

Placement of an anterior primary crown restoration

Composite strip crownDEVICE

Placement of an anterior primary crown restoration

Eligibility

Sex: ALLMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Washington-The Center for Pediatric Dentistry

Seattle, Washington, United States

Outcomes

Primary Outcomes

Fitting

The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention 1. Moderate natural retention 2. Little or no natural retention A higher score means a worse outcome

Time frame: 12 months

Positioning

Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position 1. Rotated - in occlusion 2. Not in occlusion with or without rotation A higher score means a worse outcome

Time frame: 12 months

Proximal Contact

The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces 1. Floss meets little or no resistance when passes through contact 2. Floss meets significant when passes through contact A higher score means a worse outcome

Time frame: 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 1. Detectable discrepancies but clinically acceptable 2. Detectable discrepancies, not acceptable -replacement required A higher score means a worse outcome

Time frame: 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 1. Outside range for yellow, yellow/brown discoloration or gray discoloration 2. Outside range for reason other than yellowing or graying A higher score means a worse outcome

Time frame: 12 months

Gingival Status

The number of teeth scored in the gingival status categories described below Gingival status 0=Pink, firm, free of inflammation 1. Red and/or inflamed - no bleeding on probing 2. Spontaneous and excessive bleeding on probing A higher score means a worse outcome

Data from ClinicalTrials.gov

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