Prosthetic options for full-arch implant cases in complete tooth loss: zirconia vs titanium frameworks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized trial, adults with complete edentulism who need a full-arch, screw-retained implant-supported prosthesis will be assigned to receive either a monolithic zirconia prosthesis or a CNC-milled titanium framework with a zirconia superstructure. The study will compare prosthetic complication rates and patient-reported oral health quality of life over 12 months. Procedures involve placing 4 to 6 implants in the treatment arch and fabricating a full-arch prosthesis accordingly. Outcomes will help determine if one material approach offers fewer complications and better patient-perceived function and comfort. The trial is conducted at Cairo University, with lead sponsorship from Cairo University and no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Faculty of Dentistry - Cairo University
  Cairo, Egypt Recruiting

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.