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Completed

NCT Number: NCT07369583

Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology

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.

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Key information

Age range

40 month–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Shibīn al Kawm, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Marginal bone loss

    Time frame: 12 months post-implant placement

    Marginal bone loss will be evaluated using periapical radiographs

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

Monolithic Zirconia Full-Arch Rehabilitation Using a Motion-Integrated Digital Workflow Combining M-4 and All-on-4 Protocols: A Clinical Report

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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