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CompletedNCT07369583Updated Jan 27, 2026

Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology

An interventional study of Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses in Edentulous Jaw, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 40 Months to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
40 Months to 60 Years
Sex
All
01

Study summary

20 edentulous patients presented for full-arch rehabilitation and was managed using a motion-integrated, fully digital workflow that combined the M-4 protocol in the maxilla with the All-on-4 concept in the mandible. Dual-scan CBCT and facial scans enabled prosthetically driven planning, while stackable and mucosa-supported surgical guides facilitated precise implant placement. Real-time jaw-motion data were incorporated into the design process to individualize occlusion, and definitive monolithic zirconia prostheses were fabricated and delivered on titanium multi-unit abutments using Rosen screws.

Read the detailed description

20 edentulous patients sought comprehensive full-arch rehabilitation to improve function, esthetics, and overall oral comfort. Management was performed using a fully digital, motion-integrated workflow that strategically combined two established implant protocols: the M-4 technique in the maxilla to maximize anterior anchorage in areas of limited bone volume, and the All-on-4 concept in the mandible to provide stable posterior support with tilted distal implants. Treatment planning began with dual-scan CBCT imaging and high-resolution facial scans, allowing accurate alignment of skeletal, dental, and soft-tissue datasets for prosthetically driven virtual design. A stackable guide system was employed in the maxilla to sequentially guide fixation, osteotomy preparation, and implant placement, whereas a mucosa-supported guide was used in the mandible to ensure stable positioning on the residual ridge. During the prosthetic phase, real-time mandibular motion was recorded and integrated into the CAD software to refine occlusal morphology according to the patient's functional movements. Definitive monolithic zirconia full-arch prostheses were then digitally fabricated and secured to titanium multi-unit abutments using Rosen screws, providing a rigid, precise, and metal-free restorative solution. This coordinated workflow addressed both functional and esthetic demands, enabling an efficient, patient-specific approach to immediate full-arch rehabilitation.

02

Conditions studied

  • Edentulous Jaw

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03

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 20 is below the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Months to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults aged 40-65 years with edentulism in one or both arches.
  • Adequate bone volume in the anterior maxilla for M-4 protocol and mandible for All-on-4 placement.
  • Willingness to undergo full-arch implant rehabilitation using a digital workflow.
  • Ability to provide informed consent and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  • Systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes, immunosuppression).
  • Active oral infections or untreated periodontal disease.
  • Heavy smokers (>10 cigarettes/day) or substance abuse.
  • History of head and neck radiation therapy or bisphosphonate use.
  • Pregnancy or breastfeeding.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Motion-integrated digital full-arch rehabilitation (M-4 maxilla / All-on-4 mandible)

    A fully digital, motion-integrated implant rehabilitation protocol combining the M-4 concept in the maxilla and the All-on-4 concept in the mandible. The arm included prosthetically driven planning using CBCT, intraoral and facial scanning, stackable and mucosa-supported surgical guides, immediate loading, jaw-motion tracking-guided occlusal design, and definitive monolithic zirconia full-arch prostheses connected to titanium multi-unit abutments.

    Device: Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses

Interventions

  • DeviceMotion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses

    Participants will undergo full-arch implant rehabilitation using a fully digital, motion-integrated workflow. In the maxilla, the M-4 protocol will guide anterior implant placement in areas of limited bone, while the mandible will be rehabilitated using the All-on-4 concept with tilted posterior implants. Dual-scan CBCT and facial scans will enable prosthetically driven planning, and surgical guides-stackable in the maxilla and mucosa-supported in the mandible-will ensure precise implant placement. Real-time mandibular motion data will be incorporated into the CAD design to optimize occlusion. Definitive monolithic zirconia prostheses will be fabricated and delivered on titanium multi-unit abutments using Rosen screws, providing immediate, rigid, and esthetic full-arch restoration.

06

What researchers measure

Primary outcomes

  1. Marginal bone loss

    Marginal bone loss will be evaluated using periapical radiographs

    Time frame: 12 months post-implant placement

07

Study locations

1 site
  • Faculty of Dentistry
    Shibīn al Kawm, Egypt
08

References and documents

Individual participant data

Plan to share: No — Up on reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07369583
Lead sponsor
Menoufia University
Collaborators
Mansoura University
Responsible party
Mohammed El-Sawy (Clinical Professor and principle investigator, Menoufia University) — Principal investigator
First posted
Jan 27, 2026
Start date
Jan 1, 2024
Primary completion
Nov 1, 2025
Completion
Jan 1, 2026
Last update
Jan 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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