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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 uppdaterad 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

12

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

      • Cairo, Egypten, 11553
        • Rekrytering
        • Faculty of Dentistry - Cairo University
        • Kontakt:

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

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

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: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • 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.
Andra namn:
  • CNC-milled titanium framework

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prosthetic complications
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Oral Health-Related Quality of Life (OHRQoL)
Tidsram: 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

Samarbetspartners och utredare

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

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)

12 april 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

14 juni 2026

Först inskickad som uppfyllde QC-kriterierna

14 juni 2026

Första postat (Faktisk)

18 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juni 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 09062026

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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