NCT07657364RecruitingNot Applicable
Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 12
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Single-blind (Statistician)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Pregnancy or lactation.
- •Participation in another interventional clinical trial.
- •Perceived inability to comply with the study protocol and follow-up schedule.
Investigators
Ahmad Diab Ahmad ElSayed
PhD researcher
Cairo University
Study Sites (1)
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