Edentulous JawNCT07369583
Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology
A study testing Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses in people with Edentulous Jaw, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 months to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 months to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monolithic Zirconia Full-Arch Rehabilitation Using a Motion-Integrated Digital Workflow Combining M-4 and All-on-4 Protocols: A Clinical Report
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.
- Conditions
- Edentulous Jaw
- Being tested
- Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia ProsthesesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Marginal bone loss will be evaluated using periapical radiographs
Measured: 12 months post-implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369583
- Sponsor's protocol ID
- ADMNF-0050
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monolithic Zirconia Full-Arch Rehabilitation Using a Motion-Integrated Digital Workflow Combining M-4 and All-on-4 Protocols: A Clinical Report
- ClinicalTrials.gov ID
- NCT07369583
- Acronym / sponsor ID
- ADMNF-0050
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motion-integrated digital full-arch rehabilitation (M-4 maxilla / All-on-4 mandible) | Experimental | Device: Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia ProsthesesA 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. |
Who may qualify
- Ages
- 40 months to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia ProsthesesParticipants 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. | Device | Motion-integrated digital full-arch rehabilitation (M-4 maxilla / All-on-4 mandible) |
Primary outcome
Marginal bone loss
Time frame: 12 months post-implant placement
Marginal bone loss will be evaluated using periapical radiographs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. Up on reasonable request
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Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses in people with Edentulous Jaw, run by Menoufia 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: 12 months post-implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.