- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02995876
The Clinical Performance of Inlay Zirconia Bridges
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Damascus, Syrská Arabská republika, DM20AM18
- Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Good oral hygiene
- Low susceptibility to caries
- Parallel alignment of abutment teeth
- Immobility of the abutment teeth
- Minimum height of abutment teeth ≥ 5 mm (connector thickness)
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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.
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Experimentální: 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.
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A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
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Experimentální: 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.
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A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in marginal fit
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Material Integrity
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in the Retention Status
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The resistance of a prosthesis to displacement will be measured.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Marginal Color Matching
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Sensitivity
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The presence of any spontaneous or stimulated pain will be assumed.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Patients' Satisfaction
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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A questionnaire will be used to detect the level of satisfaction regarding function and shade
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Shade
Časové okno: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The shade is going to be determined using Vita(R) shade guide.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mansour Abo Alkasab, DDS MSc, PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
- Ředitel studie: Jihad Abo Nassar, DDS MSc PhD, Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Publikace a užitečné odkazy
Obecné publikace
- Coelho PG, Bonfante EA, Silva NR, Rekow ED, Thompson VP. Laboratory simulation of Y-TZP all-ceramic crown clinical failures. J Dent Res. 2009 Apr;88(4):382-6. doi: 10.1177/0022034509333968.
- Cura C, Ozcan M, Isik G, Saracoglu A. Comparison of alternative adhesive cementation concepts for zirconia ceramic: glaze layer vs zirconia primer. J Adhes Dent. 2012 Feb;14(1):75-82. doi: 10.3290/j.jad.a21493.
- Monaco C, Ferrari M, Caldari M, Baldissara P, Scotti R. Comparison of 2 bonding systems and survival of fiber-reinforced composite inlay fixed partial dentures. Int J Prosthodont. 2006 Nov-Dec;19(6):577-85.
- Raigrodski AJ, Chiche GJ, Potiket N, Hochstedler JL, Mohamed SE, Billiot S, Mercante DE. The efficacy of posterior three-unit zirconium-oxide-based ceramic fixed partial dental prostheses: a prospective clinical pilot study. J Prosthet Dent. 2006 Oct;96(4):237-44. doi: 10.1016/j.prosdent.2006.08.010.
- Sanli S, Comlekoglu MD, Comlekoglu E, Sonugelen M, Pamir T, Darvell BW. Influence of surface treatment on the resin-bonding of zirconia. Dent Mater. 2015 Jun;31(6):657-68. doi: 10.1016/j.dental.2015.03.004. Epub 2015 Apr 7.
- Valentino TA, Borges GA, Borges LH, Platt JA, Correr-Sobrinho L. Influence of glazed zirconia on dual-cure luting agent bond strength. Oper Dent. 2012 Mar-Apr;37(2):181-7. doi: 10.2341/10-220-L. Epub 2011 Dec 14.
- Chaar MS, Kern M. Five-year clinical outcome of posterior zirconia ceramic inlay-retained FDPs with a modified design. J Dent. 2015 Dec;43(12):1411-5. doi: 10.1016/j.jdent.2015.11.001. Epub 2015 Nov 10.
- Monaco C, Cardelli P, Ozcan M. Inlay-retained zirconia fixed dental prostheses: modified designs for a completely adhesive approach. J Can Dent Assoc. 2011;77:b86.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- UDDS-FixPro-02-2016
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