Clinical Trial NuSmile Crowns

NCT04975321 | Completed Results FDA Device

• 1 other identifier: STUDY00003980
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Dental Caries, Multisurface Origin (Diagnosis)

Keywords

Anterior primary teeth restorations

Outcome Measures

Primary Outcomes (13)

• 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

  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

  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

  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

  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

  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

  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 1. Partially missing - one third missing 2. 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

Study Arms (3)

Nu Smile Zirconia crown

ACTIVE COMPARATOR

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

Device: Nu Smile Zirconia crown

Nu Smile pre veneered crown

ACTIVE COMPARATOR

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

Device: Nu Smile Pre Veneered crown

Composite strip crown

ACTIVE COMPARATOR

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

Device: Composite strip crown

Interventions

Nu Smile Zirconia crown DEVICE

Placement of an anterior primary crown restoration

Nu Smile Zirconia crown

Nu Smile Pre Veneered crown DEVICE

Placement of an anterior primary crown restoration

Nu Smile pre veneered crown

Composite strip crown DEVICE

Placement of an anterior primary crown restoration

Composite strip crown

Eligibility Criteria

• Age: Up to 5 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington-The Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Many families had moved, changed or lost phone services, or were otherwise unable to be reached. There were also a few families who withdrew following treatment due to a disinterest in travelling the distance for follow-up care. The loss of follow up was similar for all treatment groups.

Results Point of Contact

• Title: Mariella Garcia
• Organization: University of Washington

mgarciaf@uw.edu

2065431740

Study Officials

• Mariella Garcia, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Dentistry: Dept. of Pediatric Dentistry

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: July 23, 2021
• Study Start: June 6, 2015
• Primary Completion: October 16, 2018
• Study Completion: July 19, 2019
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)