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Clinical Trial NuSmile Crowns

12. april 2022 opdateret af: Mariella Garcia, University of Washington

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

97

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98115
        • University of Washington-The Center for Pediatric Dentistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 5 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Nu Smile Zirconia crown
Anterior primary teeth which received a NuSmile zirconia crown as a final restoration
Enhed: Nu Smile Zirconia crown
Placement of an anterior primary crown restoration
Aktiv komparator: Nu Smile pre veneered crown
Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration
Enhed: Nu Smile Pre Veneered crown
Placement of an anterior primary crown restoration
Aktiv komparator: Composite strip crown
Anterior primary teeth which received a composite strip crown as a final restoration
Enhed: Composite strip crown
Placement of an anterior primary crown restoration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fitting
Tidsramme: 12 months

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
Tidsramme: 12 months

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
Tidsramme: 12 months

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
Tidsramme: 12 months

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
Tidsramme: 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

  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
Tidsramme: 12 months

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
Tidsramme: 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
12 months
Integrity of the Veneer/Composite
Tidsramme: 12 months

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
Tidsramme: 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
12 months
History of Trauma
Tidsramme: 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
12 months
Clinical Pulp Pathology
Tidsramme: 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 months
Radiographical Pulp Pathology
Tidsramme: 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
12 months
Parent's Esthetic Satisfaction
Tidsramme: 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
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Efterforskere

  • Ledende efterforsker: Mariella Garcia, DDS, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. juni 2015

Primær færdiggørelse (Faktiske)

16. oktober 2018

Studieafslutning (Faktiske)

19. juli 2019

Datoer for studieregistrering

Først indsendt

1. juni 2021

Først indsendt, der opfyldte QC-kriterier

13. juli 2021

Først opslået (Faktiske)

23. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00003980

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Sponsor / samarbejdspartnere

Placeringer

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