Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology

NCT07369583 | Completed

• 1 other identifier: ADMNF-0050
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Marginal bone loss

  Marginal bone loss will be evaluated using periapical radiographs

  12 months post-implant placement

Study Arms (1)

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

EXPERIMENTAL

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

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

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.

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

Eligibility Criteria

• Age: 40 Months - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead
• Mansoura University: collaborator

Study Sites (1)

Faculty of Dentistry

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and principle investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 27, 2026
• Study Start: January 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)