Bone LossNCT07353619
All-on-X Stackable Guides for Maxillary Terminal Dentition
An observational study of Bone Loss, run by Menoufia University at 1 site in Egypt.
Trial summary
This retrospective study will evaluate the clinical performance of maxillary All-on-X(full-arch implant-supported rehabilitation) implant rehabilitation using stackable guided surgery and immediate loading. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- Maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery workflow with immediate loading.
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 May 2026
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients with terminal maxillary dentition who underwent rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis using a fully digital stackable guided surgery workflow and immediate loading protocol. Patients included had complete clinical and radiographic records available and were followed for a minimum of 2 years. Prosthetic designs were limited to FP-1 or FP-2 according to Misch classification. Patients with uncontrolled systemic conditions, previous head and neck radiotherapy, untreated infections, or requiring simultaneous bone grafting were excluded.
Who may be able to join
- Adult patients presenting with terminal dentition of the maxillary arch
- Rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis
- Treatment performed using a fully digital stackable guided surgery workflow
- Immediate loading with a provisional fixed prosthesis
- Availability of complete clinical and radiographic records
- Minimum follow-up period of 2 years
- Prosthetic design classified as (Fixed prosthesis) FP-1 or FP-2 according to Misch classification
Who cannot join
- Uncontrolled systemic conditions contraindicating implant surgery
- History of head and neck radiotherapy
- Presence of untreated periodontal or peri-implant infection at the time of surgery
- Incomplete or missing clinical or radiographic records
- Cases requiring simultaneous bone grafting procedures
- Severe maxillary atrophy (Cawood and Howell Class III-V)
- Cases requiring FP-3 prosthetic design
- Rehabilitation performed without guided surgery or without immediate loading
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
- Recruiting
Faculty of Dentistry
Shibīn al Kawm, Menoufia
Mohammed El-Sawy, 00201061314522, Dr_sawy@windowslive.com
About this study
Official title: All-on-X (Full-arch Implant-supported Rehabilitation) Stackable Surgical Guides for Maxillary Terminal Dentition: a 2-year Retrospective Analysis
This retrospective study will evaluate the clinical performance of maxillary All-on-X(full-arch implant-supported rehabilitation) implant rehabilitation using stackable guided surgery and immediate loading. Implant survival and peri-implant outcomes will be assessed over a 2-year follow-up, with regression analysis will be used to investigate the influence of surgical and prosthetic variables, including basal seating guide design.
Read the detailed description
This study is a retrospective analysis of data derived from a prospectively maintained clinical database evaluating the clinical performance of maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery protocol with immediate loading.
Consecutive patients presenting with terminal maxillary dentition were treated with a maxillary All-on-6 implant-supported complete fixed dental prosthesis (ISCFDP) using a prosthetically driven digital workflow. Implant planning was performed using three-dimensional imaging and dedicated implant planning software, allowing for virtual determination of implant number, position, angulation, and depth in relation to the planned prosthesis. Stackable surgical guides were designed and fabricated to allow guided bone reduction when indicated, followed by fully guided implant placement.
All implants were placed under local anesthesia using a standardized surgical protocol. Implants achieving a minimum insertion torque of 35 Ncm were immediately loaded with a screw-retained provisional fixed prosthesis on multi-unit abutments. Occlusal contacts were minimized during the healing phase to reduce functional loading. Patients were followed according to a predefined clinical and radiographic follow-up schedule for a minimum period of two years.
The primary outcome of the study will be implant survival at 6 months after placement. Secondary outcomes will include peri-implant clinical parameters (plaque index, bleeding on probing, and probing depth), marginal bone level changes which will be assessed on standardized periapical radiographs at prosthesis delivery, 1-year, and 2-year follow-up visits, and implant success according to established criteria.
- Conditions
- Bone Loss
- Being tested
- Maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery workflow with immediate loading.
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery workflow with immediate loading.Other
Also called Stackable guided implant surgery
Patients underwent maxillary full-arch implant rehabilitation using an All-on-X concept performed with a fully digital stackable guided surgery workflow and an immediate loading protocol. Implant placement was planned prosthetically using three-dimensional imaging and digital planning software. Stackable surgical guides were used to facilitate guided bone reduction when indicated and fully guided implant placement.
Six implants were placed in the maxillary arch under local anesthesia following a standardized surgical protocol. Implants achieving adequate primary stability were immediately restored with a screw-retained provisional fixed prosthesis supported by multi-unit abutments. Patients were followed according to a predefined clinical and radiographic protocol for outcome assessment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rate
Implant survival was defined as the presence of the implant in situ without removal for any reason, including biological or mechanical failure. Survival was assessed clinically and radiographically following implant placement and immediate loading.
Measured: 6 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
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
- Investigators
- Mohammed El-Sawy, PhD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353619
- Sponsor's protocol ID
- ADMNF-002026
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-on-X (Full-arch Implant-supported Rehabilitation) Stackable Surgical Guides for Maxillary Terminal Dentition: a 2-year Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07353619
- Acronym / sponsor ID
- ADMNF-002026
- Conditions
- Bone Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 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.
This retrospective study will evaluate the clinical performance of maxillary All-on-X(full-arch implant-supported rehabilitation) implant rehabilitation using stackable guided surgery and immediate loading. Implant survival and peri-implant outcomes will be assessed over a 2-year follow-up, with regression analysis will be used to investigate the influence of surgical and prosthetic variables, including basal seating guide design.
Detailed description
This study is a retrospective analysis of data derived from a prospectively maintained clinical database evaluating the clinical performance of maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery protocol with immediate loading.
Consecutive patients presenting with terminal maxillary dentition were treated with a maxillary All-on-6 implant-supported complete fixed dental prosthesis (ISCFDP) using a prosthetically driven digital workflow. Implant planning was performed using three-dimensional imaging and dedicated implant planning software, allowing for virtual determination of implant number, position, angulation, and depth in relation to the planned prosthesis. Stackable surgical guides were designed and fabricated to allow guided bone reduction when indicated, followed by fully guided implant placement.
All implants were placed under local anesthesia using a standardized surgical protocol. Implants achieving a minimum insertion torque of 35 Ncm were immediately loaded with a screw-retained provisional fixed prosthesis on multi-unit abutments. Occlusal contacts were minimized during the healing phase to reduce functional loading. Patients were followed according to a predefined clinical and radiographic follow-up schedule for a minimum period of two years.
The primary outcome of the study will be implant survival at 6 months after placement. Secondary outcomes will include peri-implant clinical parameters (plaque index, bleeding on probing, and probing depth), marginal bone level changes which will be assessed on standardized periapical radiographs at prosthesis delivery, 1-year, and 2-year follow-up visits, and implant success according to established criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with terminal maxillary dentition who underwent rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis using a fully digital stackable guided surgery workflow and immediate loading protocol. Patients included had complete clinical and radiographic records available and were followed for a minimum of 2 years. Prosthetic designs were limited to FP-1 or FP-2 according to Misch classification. Patients with uncontrolled systemic conditions, previous head and neck radiotherapy, untreated infections, or requiring simultaneous bone grafting were excluded.
Key inclusion criteria (7 listed)
- Adult patients presenting with terminal dentition of the maxillary arch
- Rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis
- Treatment performed using a fully digital stackable guided surgery workflow
- Immediate loading with a provisional fixed prosthesis
- Availability of complete clinical and radiographic records
Key exclusion criteria (8 listed)
- Uncontrolled systemic conditions contraindicating implant surgery
- History of head and neck radiotherapy
- Presence of untreated periodontal or peri-implant infection at the time of surgery
- Incomplete or missing clinical or radiographic records
- Cases requiring simultaneous bone grafting procedures
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 |
|---|---|---|
| Maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery workflow with immediate loading.Also: Stackable guided implant surgeryPatients underwent maxillary full-arch implant rehabilitation using an All-on-X concept performed with a fully digital stackable guided surgery workflow and an immediate loading protocol. Implant placement was planned prosthetically using three-dimensional imaging and digital planning software. Stackable surgical guides were used to facilitate guided bone reduction when indicated and fully guided implant placement. Six implants were placed in the maxillary arch under local anesthesia following a standardized surgical protocol. Implants achieving adequate primary stability were immediately restored with a screw-retained provisional fixed prosthesis supported by multi-unit abutments. Patients were followed according to a predefined clinical and radiographic protocol for outcome assessment. | Other | – |
Primary outcome
Implant Survival Rate
Time frame: 6 months after implant placement
Implant survival was defined as the presence of the implant in situ without removal for any reason, including biological or mechanical failure. Survival was assessed clinically and radiographically following implant placement and immediate loading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Up on request from the corresponding author
Related trials for Bone Loss
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
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.
Mohammed El-Sawy, PhD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss, 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 7 inclusion and 8 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 20 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?
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?
Contact Mohammed El-Sawy, PhD (00201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival Rate (time frame: 6 months after 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 20 Jan 2026.