Clinical Trial NuSmile Crowns

NCT ID: NCT04975321

Last Updated: 2022-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-06

Study Completion Date

2019-07-19

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.

Conditions

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Primary Dental Caries, Multisurface Origin (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nu Smile Zirconia crown

Anterior primary teeth which received a NuSmile zirconia crown as a final restoration

Group Type ACTIVE_COMPARATOR

Nu Smile Zirconia crown

Intervention Type DEVICE

Placement of an anterior primary crown restoration

Nu Smile pre veneered crown

Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration

Group Type ACTIVE_COMPARATOR

Nu Smile Pre Veneered crown

Intervention Type DEVICE

Placement of an anterior primary crown restoration

Composite strip crown

Anterior primary teeth which received a composite strip crown as a final restoration

Group Type ACTIVE_COMPARATOR

Composite strip crown

Intervention Type DEVICE

Placement of an anterior primary crown restoration

Interventions

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Nu Smile Zirconia crown

Placement of an anterior primary crown restoration

Intervention Type DEVICE

Nu Smile Pre Veneered crown

Placement of an anterior primary crown restoration

Intervention Type DEVICE

Composite strip crown

Placement of an anterior primary crown restoration

Intervention Type DEVICE

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
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Mariella Garcia

Associate Professor, School of Dentistry: Dept. of Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariella Garcia, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington-The Center for Pediatric Dentistry

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY00003980

Identifier Type: -

Identifier Source: org_study_id

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