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The Clinical Performance of Inlay Zirconia Bridges

9. september 2018 opdateret af: Damascus University

The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs

When missing tooth structure or teeth are replaced, minimal biologic risk should be involved to re-establish function and esthetics. The increased use of the adhesive technique and preservation of dental tissues have greatly impacted conservative tooth preparation design. The development use of zirconia technology and all-ceramic systems has opened the potential for fabrication inlays zirconia bridges with durability and good aesthetics.

The purpose of this study is to clinically evaluate the placement of inlay bridge made of a Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive approach in the replacement of a single missing tooth.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with three designs in the replacement process of one single tooth (i.e. a missing premolar or molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press.

The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with glaze layer to improve the adhesion.

The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with a layer of e-max ceramic press to improve the adhesion.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Syrien Arabiske Republik
      • Damascus, Syrien Arabiske Republik, DM20AM18
        • Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

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

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Good oral hygiene
  2. Low susceptibility to caries
  3. Parallel alignment of abutment teeth
  4. Immobility of the abutment teeth
  5. Minimum height of abutment teeth ≥ 5 mm (connector thickness)
  6. Maximum mesio-distal extension of the inter-dental gap of 9 mm (width of premolar) or 12 mm (width of molar)

Exclusion Criteria:

  • Severe para-functional habits.
  • Short clinical crowns (<5 mm)
  • Extensive defects of the clinical crown,
  • Loosening of teeth because of factors related to the periodontal tissues.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Zirconia and E-max Press
The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
Eksperimentel: Zirconia and E-max Press and Glaze
The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with a glaze layer to improve adhesion.
Procedure: Glaze layer
A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
Eksperimentel: Zirconia and E-max Press twice
The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with an E-max Press layer to improve adhesion.
Procedure: E-max Press layer
A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in marginal fit
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in Material Integrity
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in the Retention Status
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
The resistance of a prosthesis to displacement will be measured.
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Marginal Color Matching
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Sensitivity
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
The presence of any spontaneous or stimulated pain will be assumed.
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in Patients' Satisfaction
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
A questionnaire will be used to detect the level of satisfaction regarding function and shade
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
Change in Shade
Tidsramme: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
The shade is going to be determined using Vita(R) shade guide.
Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

Samarbejdspartnere og efterforskere

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

Sponsor

Damascus University

Efterforskere

  • Ledende efterforsker: Mansour Abo Alkasab, DDS MSc, PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
  • Studieleder: Jihad Abo Nassar, DDS MSc PhD, Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. juni 2016

Primær færdiggørelse (Faktiske)

15. januar 2018

Studieafslutning (Faktiske)

15. august 2018

Datoer for studieregistrering

Først indsendt

14. december 2016

Først indsendt, der opfyldte QC-kriterier

14. december 2016

Først opslået (Skøn)

19. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • UDDS-FixPro-02-2016

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Tandkroner

Kliniske forsøg med Glaze layer

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Sponsor / samarbejdspartnere

Placeringer

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