NCT07657364 Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial
| NCT ID | NCT07657364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Complete Edentulism |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04-12 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-04-12 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07657364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Complete Edentulism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07657364 currently recruiting?
Yes, NCT07657364 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cairo University to inquire about joining.
Where is the NCT07657364 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07657364 clinical trial?
NCT07657364 is sponsored by Cairo University. The trial plans to enroll 12 participants.