- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06406582
Behandlingsresultat av Zirconia Laminat Finer
Overflatekondisjoneringseffektivitet, nøyaktighet og behandlingsresultat av Zirconia laminatfiner
This study aims to evaluate the clinical performance of the zirconia laminate veneer, a minimally invasive prosthetic restoration
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients with indications for single tooth restoration with ceramic laminate veneers are recruited for the study. These indications include spaced, discolored, malformed, root canal-treated, chipped, and mildly crowded teeth. After providing written informed consent, all patients are randomly divided into two groups in a double-blind manner (participants and the outcomes assessor) in a 1:1 ratio, including the Zirconia group (intervention) and the Lithium Disilicate group (control). Each patient's tooth is prepared and restored with the corresponding laminate veneer material, that is, zirconia and lithium disilicate.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Hanoi
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Hanoi, Hanoi, Vietnam, 10000
- High Technical Center of Dentistry, School of Dentistry
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Spaced tooth
- Discolored tooth
- Malformed tooth
- Root canal-treated tooth
- Chipped tooth
- Mildly crowded tooth
Exclusion Criteria:
- Tooth bruxism
- Inadequate enamel for bonding
- Large restoration exists
- Bad oral habits harming restoration
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Zirconia laminate veneer
Intervention: Single-tooth restoration using zirconia ceramic laminate veneers. Procedure: Tooth preparation following standard protocols for laminate veneer placement. Fabrication of zirconia laminate veneers. Cementation of zirconia laminate veneers with appropriate bonding protocol. Follow-Up: after 2 weeks, 6 months, and 12 months |
Zirconia veneers are milled with computer-aided manufacturing technology from multilayered zirconia discs with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with a hydrofluoric acid-nitric acid mixture. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA). |
|
Aktiv komparator: Lithium Disilicate laminate veneer
Intervention: Single-tooth restoration using lithium disilicate ceramic laminate veneers. Procedure: Tooth preparation following standard protocols for laminate veneer placement. Fabrication of lithium disilicate laminate veneers. Cementation of lithium disilicate laminate veneers with appropriate bonding protocol. Follow-Up: after 2 weeks, 6 months, and 12 months |
Lithium Disilicate veneers are milled with computer-aided manufacturing technology from lithium disilicate blocks with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with hydrofluoric acid. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Marginal and internal fit
Tidsramme: Before veneer adhesion
|
Measurement of marginal and internal fit in micrometers with silicone replica method |
Before veneer adhesion
|
|
Gingival health
Tidsramme: 2 weeks, 6 months, 12 months
|
Assessment of gingival index |
2 weeks, 6 months, 12 months
|
|
Periodontal pocket
Tidsramme: 2 weeks, 6 months, 12 months
|
Measurement of periodontal pocket depth in millimeters |
2 weeks, 6 months, 12 months
|
|
Evaluation criteria based on the modified United States Public Health Standard
Tidsramme: 2 weeks, 6 months, 12 months
|
Shade match, contour, fracture, loss of retention, hypersensitivity |
2 weeks, 6 months, 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 01050122106
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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