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Complete EdentulismNCT07657364

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

A study testing Monolithic Zirconia Prosthesis and CNC-milled titanium framework and zirconia superstructure in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Complete Edentulism
What is being tested?
Monolithic Zirconia Prosthesis and CNC-milled titanium framework and zirconia superstructure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteEgypt
Study dates
12 Apr 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting

  • Faculty of Dentistry - Cairo University

    Cairo, 11553

    Faculty of Dentistry - Cairo University, 0020223642705, dentmail@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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.

Being tested
Monolithic Zirconia Prosthesis, CNC-milled titanium framework and zirconia superstructure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monolithic Zirconia ProsthesisOther

    Also called Screw-Retained Monolithic Zirconia Prosthesis

    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.

  • CNC-milled titanium framework and zirconia superstructureOther

    Also called CNC-milled titanium framework

    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.

Study groups in NCT07657364
Study groupRoleWhat they receive
Monolithic zirconia frameworkExperimentalThe 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.
Receives: Other: Monolithic Zirconia Prosthesis
CNC-milled titanium framework and zirconia superstructureActive comparatorThe 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.
Receives: Other: CNC-milled titanium framework and zirconia superstructure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Secondary outcomes (1)

  1. Oral Health-Related Quality of Life (OHRQoL)

    The secondary outcome of this study is the change in Oral Health-Related Quality of Life (OHRQoL) over the 12-month follow-up period. This will be measured using the validated Arabic version of the 5-item Oral Health Impact Profile (OHIP5-Ar) questionnaire (Alhajj et al., 2019). The questionnaire consists of 5 questions, each rated on a Likert scale (e.g., 0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, 4 = Very often). The total score ranges from 0 to 20, with a higher score indicating a greater negative impact on OHRQoL. The change from baseline to 3, 6 and 12 months will be analyzed.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start12 Apr 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a two-arm, parallel-group, randomized controlled superiority trial with a 1:1 allocation ratio.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07657364
Sponsor's protocol ID
09062026
Status last verified
Apr 2026
First submitted
14 Jun 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Monolithic Zirconia Prosthesis and CNC-milled titanium framework and zirconia superstructure in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prosthetic complications (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07657364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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