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The Clinical Performance of Inlay Zirconia Bridges

9 september 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: 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.
A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
Experimentell: 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.
A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in marginal fit
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Marginal Color Matching
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Sensitivity
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2016

Primärt slutförande (Faktisk)

15 januari 2018

Avslutad studie (Faktisk)

15 augusti 2018

Studieregistreringsdatum

Först inskickad

14 december 2016

Först inskickad som uppfyllde QC-kriterierna

14 december 2016

Första postat (Uppskatta)

19 december 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • UDDS-FixPro-02-2016

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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