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

NCT07657364 | Recruiting DMC

• 1 other identifier: 09062026
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

• Prosthetic complications

  The primary outcome of this study is the incidence of prosthetic complications over 12-month follow-up period. A prosthetic complication is defined as any mechanical or technical issue affecting the prosthesis that requires clinical intervention. This will be assessed through a standardized clinical examination conducted by a calibrated examiner. The outcome for each participant will be recorded as a binary variable (Yes/No).

  1 year

Secondary Outcomes (1)

• Oral Health-Related Quality of Life (OHRQoL)

  1 year

Study Arms (2)

Monolithic zirconia framework

EXPERIMENTAL

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.

Other: Monolithic Zirconia Prosthesis

CNC-milled titanium framework and zirconia superstructure

ACTIVE COMPARATOR

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.

Other: CNC-milled titanium framework and zirconia superstructure

Interventions

Monolithic Zirconia Prosthesis OTHER

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 each participant using a digital workflow: 1. Digital Impression: An intraoral scan (Medit i700 scanner ) of the multi-unit abutment scan bodies will be performed. 2. Prosthesis Design: The prosthesis will be digitally designed in the CAD software BlenderforDental . 3. Fabrication: The design file will be processed in Millbox CAM software and milled from a zirconia blank using a 5-axis milling machine.

Also known as: Screw-Retained Monolithic Zirconia Prosthesis

Monolithic zirconia framework

CNC-milled titanium framework and zirconia superstructure OTHER

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.

Also known as: CNC-milled titanium framework

CNC-milled titanium framework and zirconia superstructure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, 11553, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single-blind (Statistician)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher

Model Details: This study is a two-arm, parallel-group, randomized controlled superiority trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-04

Locations

EG (1)