Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial
Recruiting now · Not applicable
Conditions studied: Complete Edentulism
In brief
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.
Key facts
- Study ID
- NCT07657364
- Run by
- Cairo University
- People needed
- 12
- Starts
- 2026-04-12
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Faculty of Dentistry - Cairo University — Cairo, Egypt (enrolling)
Full record on ClinicalTrials.gov
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