Atrophic Edentulous Maxillaguided surgeryNCT07551024
Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla
A study testing Resin surgical Guide and Group B (Metallic nickel Guide) in people with Atrophic Edentulous Maxilla and Zygomatic Implants, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Some patients lose a large amount of bone in the upper jaw. When this happens, it can be difficult to place regular dental implants. In these cases, special implants called zygomatic implants can be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Edentulous Maxilla, Zygomatic Implants, Guided Surgery
- What is being tested?
- Resin surgical Guide and Group B (Metallic nickel Guide)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2025to Jun 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years with severely atrophic maxilla.
- Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
- Indicated for zygomatic implant-supported fixed prosthesis.
- Sufficient mouth opening for zygomatic implants placement.
- Patients willing to sign informed consent and attend follow-ups.
Who cannot join
- Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
- Heavy smokers
- Previous radiotherapy or bisphosphonate therapy.
- Active sinus or nasal infection.
- Severe parafunctional habits (e.g., bruxism).
- Pregnant or lactating women.
- Patients with psychiatric disorders affecting compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor contact
aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER contact
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt
New Cairo, Cairo Governorate, 11835
lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor, 00201099925769, laziz@fue.edu.eg
omar magdy elawady, Bachelor
About this study
Official title: Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Surgical Guides in Severely Atrophic Maxilla.
Some patients lose a large amount of bone in the upper jaw. When this happens, it can be difficult to place regular dental implants. In these cases, special implants called zygomatic implants can be used. These implants are longer than normal implants and are fixed in the cheekbone, which usually has enough bone to support them. They can help support fixed teeth for patients with severe bone loss in the upper jaw.
Placing zygomatic implants requires careful planning and high accuracy. To help guide the surgeon during the operation, a surgical guide can be used. A surgical guide is a custom-made device that helps the surgeon place the implant in the planned position.
Read more
Surgical guides can be made from different materials. The most common type is made from resin (a strong plastic material) using 3D printing. Recently, fully metallic surgical guides have been developed. These metal guides may be stronger and more stable during surgery, but it is not yet clear if they improve the accuracy of implant placement.
The purpose of this study is to compare the accuracy of metal surgical guides and resin surgical guides when placing zygomatic implants in patients with severe bone loss in the upper jaw.
Patients included in the study will undergo a clinical examination and a CT scan before surgery to plan the implant positions. During the surgery, each patient will receive zygomatic implants on both sides of the upper jaw. On one side, the implants will be placed using a metal surgical guide, and on the other side, they will be placed using a resin surgical guide. This allows the two types of guides to be compared in the same patient.
After the surgery, another CT scan will be taken to check the final position of the implants. The planned implant position will be compared with the actual position after surgery to measure the accuracy of placement.
The results of this study will help determine whether metallic surgical guides or resin surgical guides provide better accuracy when placing zygomatic implants.
Participation in this study is voluntary. All patients will receive full information about the study and will sign a consent form before participating.
- Conditions
- Atrophic Edentulous Maxilla, Zygomatic Implants, Guided Surgery, Dental Implant, Accuracy of Dental Implant Placement
- Being tested
- Resin surgical Guide, Group B (Metallic nickel Guide)
- Keywords
- Zygomatic implants, Severely atrophic maxilla, Surgical guides, Dental implant placement accuracy, Metal surgical guide, Resin surgical guide
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin surgical GuideDevice
Before surgery, a CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement.
On the assigned side, the zygomatic implant will be placed using this resin guide.
Group B (Metallic nickel Guide)Device
CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. , the zygomatic implant will be placed using this metallic guide on one side.
| Study group | Role | What they receive |
|---|---|---|
| Group B (Metallic nickel Guide) | Active comparator | CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created.
, the zygomatic implant will be placed using this metallic guide on one side. Receives: Device: Group B (Metallic nickel Guide) |
| Group A (Resin Guide) | Active comparator | CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement. On the assigned side, the zygomatic implant will be placed using this resin guide Receives: Device: Resin surgical Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant placement accuracy
Measured by deviation (mm, degrees) between planned and placed implant positions (CT superimposition) using computer software Using Real Guide. on each side for assessment for accuracy of implant placement in each group
Measured: from enrolment to the implant placement at 4 weeks
Secondary outcomes (3)
primary stability
the primary stability is assessed after implant placement at time of surgery using osstell in ISQ
Measured: from time of enrolment to time of surgery 2 weeks
Intraoperative Complications
This outcome assesses any adverse events or procedural difficulties occurring during zygomatic implant placement. Examples include:
Excessive bleeding beyond normal surgical expectations Damage to adjacent anatomical structures (e.g., infraorbital nerve, orbital floor ) Fracture or deformation of the surgical guide during the procedure Difficulties in achieving planned implant trajectory or insertion Any other unanticipated events affecting the safety or conduct of the surgery All intraoperative complications will be documented by the operating surgeon in real time
Measured: from enrolment to the time of surgery 2 weeks
Surgical time
This outcome measures the duration of the zygomatic implant placement procedure. Surgical time is defined as the time from the initial incision to the completion of implant placement and suture closure Time will be recorded in minutes using a standard surgical timer This outcome helps determine whether the type of surgical guide affects the operative workflow and efficiency
Measured: measured intraoperatively during surgery in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start3 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Edentulous MaxillaStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- each patient will receive zygomatic implants on both sides of the upper jaw, using two different types of surgical guides split mouth. Group A - Resin Surgical Guide: Before surgery, a CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement. On the assigned side, the zygomatic implant will be placed using this resin guide. Group B - Metallic Surgical Guide: The same CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. On the opposite side of the jaw, the zygomatic implant will be placed using this metallic guide. Both guides are used in the same surgery, one on each side of the upper jaw. This allows a direct comparison between the resin and metallic guides to see which one provides more accurate placement of the implants.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Elawady, Future University in Egypt
- Investigators
- ramy ragab el beialy, proffessor, Study chair, cairo university in egyptmohamed safwat eid, bachelor, Principal investigator, future unversity in egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551024
- Sponsor's protocol ID
- FUE.REC(92)/11-2025
- Acronym
- guided surgery
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Surgical Guides in Severely Atrophic Maxilla.
- ClinicalTrials.gov ID
- NCT07551024
- Acronym / sponsor ID
- guided surgery / FUE.REC(92)/11-2025
- Conditions
- Atrophic Edentulous Maxilla, Zygomatic Implants, Guided Surgery, Dental Implant, Accuracy of Dental Implant Placement
- Keywords
- Zygomatic implants, Severely atrophic maxilla, Surgical guides, Dental implant placement accuracy, Metal surgical guide, Resin surgical guide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Apr 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.
Some patients lose a large amount of bone in the upper jaw. When this happens, it can be difficult to place regular dental implants. In these cases, special implants called zygomatic implants can be used. These implants are longer than normal implants and are fixed in the cheekbone, which usually has enough bone to support them. They can help support fixed teeth for patients with severe bone loss in the upper jaw.
Placing zygomatic implants requires careful planning and high accuracy. To help guide the surgeon during the operation, a surgical guide can be used. A surgical guide is a custom-made device that helps the surgeon place the implant in the planned position.
Surgical guides can be made from different materials. The most common type is made from resin (a strong plastic material) using 3D printing. Recently, fully metallic surgical guides have been developed. These metal guides may be stronger and more stable during surgery, but it is not yet clear if they improve the accuracy of implant placement.
The purpose of this study is to compare the accuracy of metal surgical guides and resin surgical guides when placing zygomatic implants in patients with severe bone loss in the upper jaw.
Patients included in the study will undergo a clinical examination and a CT scan before surgery to plan the implant positions. During the surgery, each patient will receive zygomatic implants on both sides of the upper jaw. On one side, the implants will be placed using a metal surgical guide, and on the other side, they will be placed using a resin surgical guide. This allows the two types of guides to be compared in the same patient.
After the surgery, another CT scan will be taken to check the final position of the implants. The planned implant position will be compared with the actual position after surgery to measure the accuracy of placement.
The results of this study will help determine whether metallic surgical guides or resin surgical guides provide better accuracy when placing zygomatic implants.
Participation in this study is voluntary. All patients will receive full information about the study and will sign a consent form before participating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- each patient will receive zygomatic implants on both sides of the upper jaw, using two different types of surgical guides split mouth. Group A - Resin Surgical Guide: Before surgery, a CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement. On the assigned side, the zygomatic implant will be placed using this resin guide. Group B - Metallic Surgical Guide: The same CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. On the opposite side of the jaw, the zygomatic implant will be placed using this metallic guide. Both guides are used in the same surgery, one on each side of the upper jaw. This allows a direct comparison between the resin and metallic guides to see which one provides more accurate placement of the implants.
| Arm | Type | Receives |
|---|---|---|
| Group B (Metallic nickel Guide) | Active comparator | Device: Group B (Metallic nickel Guide)CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. , the zygomatic implant will be placed using this metallic guide on one side. |
| Group A (Resin Guide) | Active comparator | Device: Resin surgical GuideCT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement. On the assigned side, the zygomatic implant will be placed using this resin guide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥18 years with severely atrophic maxilla.
- Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
- Indicated for zygomatic implant-supported fixed prosthesis.
- Sufficient mouth opening for zygomatic implants placement.
- Patients willing to sign informed consent and attend follow-ups.
Key exclusion criteria (7 listed)
- Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
- Heavy smokers
- Previous radiotherapy or bisphosphonate therapy.
- Active sinus or nasal infection.
- Severe parafunctional habits (e.g., bruxism).
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 |
|---|---|---|
| Resin surgical GuideBefore surgery, a CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement. On the assigned side, the zygomatic implant will be placed using this resin guide. | Device | Group A (Resin Guide) |
| Group B (Metallic nickel Guide)CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. , the zygomatic implant will be placed using this metallic guide on one side. | Device | Group B (Metallic nickel Guide) |
Primary outcome
Implant placement accuracy
Time frame: from enrolment to the implant placement at 4 weeks
Measured by deviation (mm, degrees) between planned and placed implant positions (CT superimposition) using computer software Using Real Guide. on each side for assessment for accuracy of implant placement in each group
3 secondary outcomes
primary stability
Time frame: from time of enrolment to time of surgery 2 weeks
Intraoperative Complications
Time frame: from enrolment to the time of surgery 2 weeks
Surgical time
Time frame: measured intraoperatively during surgery in minutes
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 7 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for Atrophic Edentulous Maxilla
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
Graftless TSFE Via Self-tapping Implants
Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization
Recruiting
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
Atrophic Edentulous Maxilla, Zygomatic Implants
Not yet recruitingObservational study
Implant-supported Maxillary Overdentures; a 15-years Evaluation
Edentulous Maxilla, Atrophic, Implants, Dental
Not yet recruiting
NobelZygoma TiUltra Implant System Study
Edentulous Maxilla, Maxillary Bone Loss
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.
ahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor contact
aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER contact
ramy ragab el beialy, proffessor study chair
cairo university in egypt
mohamed safwat eid, bachelor principal investigator
future unversity in egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin surgical Guide and Group B (Metallic nickel Guide) in people with Atrophic Edentulous Maxilla and Zygomatic Implants, run by Future University in Egypt 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 5 inclusion and 7 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 7 May 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 ahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor (00201012162020 ext. 00201012162020, Ahmed.Kamal@fue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant placement accuracy (time frame: from enrolment to the implant placement at 4 weeks). 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 7 May 2026.