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Recruiting NCT07657364

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

No phase Interventional Complete Edentulism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monolithic Zirconia Prosthesis, CNC-milled titanium framework and zirconia superstructure.
Who it may be relevant to
Registry conditions: Complete Edentulism. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Monolithic Zirconia Prosthesis
    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 ea
  • Other 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.

Primary outcome measures

  • Prosthetic complications [Time frame: 1 year]
Secondary outcome measures (1)
  • Oral Health-Related Quality of Life (OHRQoL) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry - Cairo University — Cairo

Identifiers

NCT: NCT07657364 · 09062026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗