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Completed

NCT Number: NCT04975321

Clinical Trial NuSmile Crowns

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

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Key information

Conditions

Primary Dental Caries, Multisurface Origin (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington-The Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nu Smile Zirconia crown

Device

Placement of an anterior primary crown restoration

Nu Smile Pre Veneered crown

Device

Placement of an anterior primary crown restoration

Composite strip crown

Device

Placement of an anterior primary crown restoration

Primary outcomes

  1. Fitting

    Time frame: 12 months

    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

  2. Positioning

    Time frame: 12 months

    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

  3. Proximal Contact

    Time frame: 12 months

    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

  4. Marginal Adaptation

    Time frame: 12 months

    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

  5. Color

    Time frame: 12 months

    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

  6. Gingival Status

    Time frame: 12 months

    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

  7. Retention of the Crown

    Time frame: 12 months

    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

  8. Integrity of the Veneer/Composite

    Time frame: 12 months

    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

  9. Secondary Caries

    Time frame: 12 months

    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

  10. History of Trauma

    Time frame: 12 months

    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

  11. Clinical Pulp Pathology

    Time frame: 12 months

    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. Radiographical Pulp Pathology

    Time frame: 12 months

    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

  13. Parent's Esthetic Satisfaction

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jul 23, 2021
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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