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Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial

14. juni 2026 oppdatert av: Ahmad Diab Ahmad ElSayed, Cairo University
The goal of this clinical trial is to to compare the prosthetic complication rate and Oral Health-Related Quality of Life (OHRQoL) between screw-retained monolithic zirconia frameworks and CNC-milled titanium frameworks with zirconia superstructures in completely edentulous patients restored with full-arch implant-supported prostheses over a follow-up period of 12 months.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

12

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Cairo, Egypt, 11553
        • Rekruttering
        • Faculty of Dentistry - Cairo University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Aged 18 years or older.
  2. Able to understand the study procedures and provide written informed consent.
  3. In good general health, classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
  4. Completely edentulous in the arch to be treated (maxilla and/or mandible).
  5. A candidate for a full-arch, screw-retained implant-supported prosthesis, requiring 4 to 6 implants in the treatment arch.
  6. Sufficient bone volume at planned implant sites to place implants of at least 3.5mm in diameter and 8mm in length.
  7. Adequate crown height space (15-22 mm) for a fixed prosthesis.
  8. A zone of keratinized mucosa at the crest of the ridge measuring at least 2 mm in width.
  9. Opposing arch is fixed full-arch implant-supported prosthesis.
  10. Demonstrates acceptable oral hygiene and the motivation to maintain it.

Exclusion Criteria:

  1. Medical contraindications:

    • Uncontrolled diabetes (HbA1c > 7.0%).
    • History of radiotherapy in the head and neck region.
    • History of intravenous bisphosphonate therapy.
    • Immunosuppressed or immunocompromised status.
    • Any other uncontrolled systemic disease that constitutes a contraindication for oral surgery.
  2. Behavioral Factors:

    • Heavy smoking, defined as consumption of more than 10 cigarettes per day.
    • Presence of parafunctional habits (e.g., bruxism, clenching) as diagnosed by clinical examination.
  3. Local Oral Factors:

    • Active, untreated periodontal disease in any remaining dentition.
    • Presence of acute oral infection or pathology at the intended surgical site.
    • Crown height space less than 15 mm or more than 22 mm.
    • Insufficient keratinized mucosa (< 2 mm width) that cannot be corrected with a simple surgical procedure prior to implant placement.
  4. General:

    • Pregnancy or lactation.
    • Participation in another interventional clinical trial.
    • Perceived inability to comply with the study protocol and follow-up schedule.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Monolithic zirconia framework
The prosthesis is a one-piece, full-arch framework milled from a single, monolithic zirconia blank. It includes the infrastructure, prosthetic teeth, and gingival contours. The prosthesis is screw-retained directly to multi-unit abutments.

Intervention: Screw-Retained Monolithic Zirconia Prosthesis

  • Components: The prosthesis is a one-piece, full-arch framework milled from a single, monolithic zirconia blank. It includes the infrastructure, prosthetic teeth, and gingival contours. The prosthesis is screw-retained directly to multi-unit abutments. The prosthesis is delivered on the day of final insertion and is intended to be a definitive, long-term restoration.
  • Procedure for Tailoring: The prosthesis is fully customized for each participant using a digital workflow:

    1. Digital Impression: An intraoral scan (Medit i700 scanner ) of the multi-unit abutment scan bodies will be performed.
    2. Prosthesis Design: The prosthesis will be digitally designed in the CAD software BlenderforDental .
    3. Fabrication: The design file will be processed in Millbox CAM software and milled from a zirconia blank using a 5-axis milling machine.
Andre navn:
  • Screw-Retained Monolithic Zirconia Prosthesis
Aktiv komparator: CNC-milled titanium framework and zirconia superstructure

The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework.

The titanium framework is screw-retained directly to multi-unit abutments. The zirconia superstructure is permanently cemented to the framework with resin cement.

The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework. The titanium framework is screw-retained directly to multi-unit abutments. The zirconia superstructure is permanently cemented to the framework with resin cement.
Andre navn:
  • CNC-milled titanium framework

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosthetic complications
Tidsramme: 1 year
The primary outcome of this study is the incidence of prosthetic complications over 12-month follow-up period. A prosthetic complication is defined as any mechanical or technical issue affecting the prosthesis that requires clinical intervention. This will be assessed through a standardized clinical examination conducted by a calibrated examiner. The outcome for each participant will be recorded as a binary variable (Yes/No).
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oral Health-Related Quality of Life (OHRQoL)
Tidsramme: 1 year
The secondary outcome of this study is the change in Oral Health-Related Quality of Life (OHRQoL) over the 12-month follow-up period. This will be measured using the validated Arabic version of the 5-item Oral Health Impact Profile (OHIP5-Ar) questionnaire (Alhajj et al., 2019). The questionnaire consists of 5 questions, each rated on a Likert scale (e.g., 0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, 4 = Very often). The total score ranges from 0 to 20, with a higher score indicating a greater negative impact on OHRQoL. The change from baseline to 3, 6 and 12 months will be analyzed.
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. april 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

14. juni 2026

Først innsendt som oppfylte QC-kriteriene

14. juni 2026

Først lagt ut (Faktiske)

18. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 09062026

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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