Maxillary Defect ReconstructionNCT07463469
Evaluation of Accuracy of Three-Dimensionally Guided Zygomatic Implant Installation
A study testing zygomatic implant installation using custamized bone supported surgical guide in people with Maxillary Defect Reconstruction and Atrophic Edentulous Maxilla, run by Tanta University at 1 site in Egypt.
Trial summary
This study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. A prospective non-controlled clinical study was performed on ten patients with compromised zygomaticomaxillary bone. Surgical intervention was carried out using a customized surgical guide. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Maxillary Defect Reconstruction, Atrophic Edentulous Maxilla
- What is being tested?
- zygomatic implant installation using custamized bone supported surgical guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2023to 20 Dec 2025
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Lack of maxillary posterior bone in which standard implants are impossible to insert.
- 2. Post-surgical maxillary defects with limitations of maxillary bone reconstruction due to lack of soft tissue coverage.
- 3. Failure of previous reconstructive procedures.
Who cannot join
- Opportunity of alternative treatment modalities with bone grafting and standard implants.
- Any relevant systemic or local diseases that might affect the bone healing, like uncontrolled diabetic patients or cancer patients who are still on chemotherapy or previously received radiation on the head and neck region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of Three-Dimensionally Guided Zygomatic Implant Placement: A Prospective Clinical Study
This study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. A prospective non-controlled clinical study was performed on ten patients with compromised zygomaticomaxillary bone. Surgical intervention was carried out using a customized surgical guide.
Pre-surgical planning was performed using computed tomography (CT) scans for each patient. Surgical guides were fabricated using direct metal laser sintering technology. Zygomatic implants were inserted using a guided surgical protocol and specialized instruments.
Postoperative CT scans were obtained to evaluate deviations between the planned and actual implant positions. Accuracy was assessed by superimposing the postoperative implant position onto the virtual pre-surgical implant plan using dedicated software. Descriptive and bivariate statistical analyses were performed.
Read the detailed description
Purpose: The aim of this study was to evaluate the accuracy of using a static surgical guide protocol for zygomatic implant placement in patients with compromised zygomaticomaxillary bone.
Materials and methods: All the patients had a pre-operative initial consultation interview with the surgeons mainly for collecting demographic data, taking general medical, surgical, and dental history, and listening to the patient's esthetic complaints and postoperative expectations.
- A pre-operative multiplanar CT scan of the face to evaluate residual maxillary bone, zygomatic bone, and sinus condition to detect any sinus pathology. This gives initial data about the orientation of the zygomatic implant (ZI), positioning, angulation, and length using 3D planning software.
- The resulting DICOM files were segmented, forming STL (Standard Triangulation Language) files that were used as a baseline for post-operative superimposition.
- Under general anesthesia, patients underwent either contralateral nasal intubation to the working side or oral intubation.
- A palatal paracrestal incision was carried out in the maxillary soft tissues with vertical posterior releasing incisions.
- The muco-periosteal flap was elevated to expose the alveolar crest, the piriform aperture, the lateral wall of the maxillary sinus if present, the infraorbital nerve emergence, the maxillary tuberosity, and the central and the posterior part of the zygomatic bone.
- The surgical guide was fitted in its position and fixed with cortical screws. Implant osteotomy was performed. Then zygomatic implants were inserted.
- The wound was irrigated with normal saline and debridement of the surgical field before suturing using Vicryl 3/0.
Post-operative assessment:
All patients were regularly followed up on the 7th \& 14th days postoperatively to assess the following parameters:
- The oral health-related quality of life in edentulous adults was assessed using the OHIP-14 questionnaire.
Radiographic assessment:
- A post-operative CT scan of each patient with implants was taken after the surgery, with follow-up CT after 6 months and one year
- The DICOM images of the post-operative CT were uploaded in dedicated software.
- Segmentation based on tissue density was carried out to separate implants from the surrounding bone.
- The STL files of the maxillary bone with the planned implant positions obtained from the initial CT scan were uploaded into the software.
Superimposition
- The postoperative CT scan was imported into Mimics software, where the DICOM file was segmented. It was then brought into 3-matic, and the Postoperative segmentation was aligned with the planned skull using a point registration algorithm. Final refinement of the registration was completed through global registration.
- The amount of deviation was calculated by determining the same point at the center of the implant platform in both the post-operative segmentation and the plan. Then the amount of deviation was calculated by measuring the distance in millimeters between points and the vector of displacement. (coronal, apical, and angular deviations).
Radiographical evaluation:
Implant Placement Accuracy
- The implant lengths By superimposition of the postoperative implant length onto the virtually planned implant length
- The 3D implant angle deviation By measuring the deviation between the postoperative coronal entry point of the implant and the virtually planned coronal entry point
- The accuracy of the abutment position in the occlusal plane. By superimposition of the postoperative position of the multiunit abutments, onto the virtually planned abutment positions
- Being tested
- zygomatic implant installation using custamized bone supported surgical guide
- Keywords
- guided zygomatic implant surgery, Post-Mucormycosis Rehabilitation, Bone-Supported zygomatic implant 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.
zygomatic implant installation using custamized bone supported surgical guideProcedure or surgery
Zygomatic implant placement using a customized bone-supported surgical guide.
Indications included:
- Severe posterior maxillary bone deficiency preventing placement of conventional implants
- Post-surgical maxillary defects with limited options for bone reconstruction due to inadequate soft tissue coverage
- Failure of previous reconstructive procedures
| Study group | Role | What they receive |
|---|---|---|
| Single-arm interventional study | Experimental | Patients received zygomatic implants using a customized bone-supported surgical guide following three-dimensional preoperative planning. Receives: Procedure: zygomatic implant installation using custamized bone supported surgical guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant success.
Implant success was assessed based on clinical stability and osseointegration. Stability was evaluated using torque testing during implant uncovering with a torque value of 10-20 Ncm applied to the multiunit abutment screw without implant rotation.
Measured: 3 months
Implant survival
Implant survival was assessed based on the absence of implant mobility, pain, infection, peri-implant inflammation, suppuration, and progressive bone loss.
Measured: 1 year
Coronal Deviation
Deviation at the coronal entry point of the implant between the planned implant position and the actual postoperative implant position measured using three-dimensional superimposition of preoperative planning and postoperative CT scans.
Measured: 1 week
Apical Deviation
Linear deviation at the apical endpoint of the implant between the planned implant position and the postoperative implant position measured using three-dimensional image superimposition.
Measured: 1 week
Angular Deviation
Angular deviation between the long axis of the planned implant and the postoperative implant measured in degrees using 3D software analysis.
Measured: 1 week
Soft tissue wound healing:
Postoperative clinical evaluation of the surgical site including signs of inflammation, infection, or intraoral wound dehiscence.
Measured: 4 weeks
Secondary outcomes (2)
Prosthetic Survival
Evaluation of prosthetic success including structural integrity of the prosthesis, absence of fracture or wear, and stability of the implant-prosthesis connection.
Measured: 1 year
Oral Health Impact Profile (OHIP-14)
Patient-reported outcome measured using the Oral Health Impact Profile-14 questionnaire to assess functional limitation, pain, psychological discomfort, and social disability.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 Jun 2023
- Primary completion15 Nov 2024
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Defect ReconstructionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Abd elhaliem Gharieb, Tanta University
- Investigators
- Eslam A Gharieb, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463469
- Sponsor's protocol ID
- OS-3-23-13
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be shared outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Three-Dimensionally Guided Zygomatic Implant Placement: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07463469
- Acronym / sponsor ID
- OS-3-23-13
- Keywords
- guided zygomatic implant surgery, Post-Mucormycosis Rehabilitation, Bone-Supported zygomatic implant guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 11 Mar 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 study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. A prospective non-controlled clinical study was performed on ten patients with compromised zygomaticomaxillary bone. Surgical intervention was carried out using a customized surgical guide.
Pre-surgical planning was performed using computed tomography (CT) scans for each patient. Surgical guides were fabricated using direct metal laser sintering technology. Zygomatic implants were inserted using a guided surgical protocol and specialized instruments.
Postoperative CT scans were obtained to evaluate deviations between the planned and actual implant positions. Accuracy was assessed by superimposing the postoperative implant position onto the virtual pre-surgical implant plan using dedicated software. Descriptive and bivariate statistical analyses were performed.
Detailed description
Purpose: The aim of this study was to evaluate the accuracy of using a static surgical guide protocol for zygomatic implant placement in patients with compromised zygomaticomaxillary bone.
Materials and methods: All the patients had a pre-operative initial consultation interview with the surgeons mainly for collecting demographic data, taking general medical, surgical, and dental history, and listening to the patient's esthetic complaints and postoperative expectations.
- A pre-operative multiplanar CT scan of the face to evaluate residual maxillary bone, zygomatic bone, and sinus condition to detect any sinus pathology. This gives initial data about the orientation of the zygomatic implant (ZI), positioning, angulation, and length using 3D planning software.
- The resulting DICOM files were segmented, forming STL (Standard Triangulation Language) files that were used as a baseline for post-operative superimposition.
- Under general anesthesia, patients underwent either contralateral nasal intubation to the working side or oral intubation.
- A palatal paracrestal incision was carried out in the maxillary soft tissues with vertical posterior releasing incisions.
- The muco-periosteal flap was elevated to expose the alveolar crest, the piriform aperture, the lateral wall of the maxillary sinus if present, the infraorbital nerve emergence, the maxillary tuberosity, and the central and the posterior part of the zygomatic bone.
- The surgical guide was fitted in its position and fixed with cortical screws. Implant osteotomy was performed. Then zygomatic implants were inserted.
- The wound was irrigated with normal saline and debridement of the surgical field before suturing using Vicryl 3/0.
Post-operative assessment:
All patients were regularly followed up on the 7th \& 14th days postoperatively to assess the following parameters:
- The oral health-related quality of life in edentulous adults was assessed using the OHIP-14 questionnaire.
Radiographic assessment:
- A post-operative CT scan of each patient with implants was taken after the surgery, with follow-up CT after 6 months and one year
- The DICOM images of the post-operative CT were uploaded in dedicated software.
- Segmentation based on tissue density was carried out to separate implants from the surrounding bone.
- The STL files of the maxillary bone with the planned implant positions obtained from the initial CT scan were uploaded into the software.
Superimposition
- The postoperative CT scan was imported into Mimics software, where the DICOM file was segmented. It was then brought into 3-matic, and the Postoperative segmentation was aligned with the planned skull using a point registration algorithm. Final refinement of the registration was completed through global registration.
- The amount of deviation was calculated by determining the same point at the center of the implant platform in both the post-operative segmentation and the plan. Then the amount of deviation was calculated by measuring the distance in millimeters between points and the vector of displacement. (coronal, apical, and angular deviations).
Radiographical evaluation:
Implant Placement Accuracy
- The implant lengths By superimposition of the postoperative implant length onto the virtually planned implant length
- The 3D implant angle deviation By measuring the deviation between the postoperative coronal entry point of the implant and the virtually planned coronal entry point
- The accuracy of the abutment position in the occlusal plane. By superimposition of the postoperative position of the multiunit abutments, onto the virtually planned abutment positions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm interventional study | Experimental | Procedure: zygomatic implant installation using custamized bone supported surgical guidePatients received zygomatic implants using a customized bone-supported surgical guide following three-dimensional preoperative planning. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Lack of maxillary posterior bone in which standard implants are impossible to insert.
- 2. Post-surgical maxillary defects with limitations of maxillary bone reconstruction due to lack of soft tissue coverage.
- 3. Failure of previous reconstructive procedures.
Key exclusion criteria (2 listed)
- Opportunity of alternative treatment modalities with bone grafting and standard implants.
- Any relevant systemic or local diseases that might affect the bone healing, like uncontrolled diabetic patients or cancer patients who are still on chemotherapy or previously received radiation on the head and neck region.
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 |
|---|---|---|
| zygomatic implant installation using custamized bone supported surgical guideZygomatic implant placement using a customized bone-supported surgical guide. Indications included: * Severe posterior maxillary bone deficiency preventing placement of conventional implants * Post-surgical maxillary defects with limited options for bone reconstruction due to inadequate soft tissue coverage * Failure of previous reconstructive procedures | Procedure or surgery | Single-arm interventional study |
Primary outcome
implant success.
Time frame: 3 months
Implant success was assessed based on clinical stability and osseointegration. Stability was evaluated using torque testing during implant uncovering with a torque value of 10-20 Ncm applied to the multiunit abutment screw without implant rotation.
Implant survival
Time frame: 1 year
Implant survival was assessed based on the absence of implant mobility, pain, infection, peri-implant inflammation, suppuration, and progressive bone loss.
Coronal Deviation
Time frame: 1 week
Deviation at the coronal entry point of the implant between the planned implant position and the actual postoperative implant position measured using three-dimensional superimposition of preoperative planning and postoperative CT scans.
Apical Deviation
Time frame: 1 week
Linear deviation at the apical endpoint of the implant between the planned implant position and the postoperative implant position measured using three-dimensional image superimposition.
Angular Deviation
Time frame: 1 week
Angular deviation between the long axis of the planned implant and the postoperative implant measured in degrees using 3D software analysis.
Soft tissue wound healing:
Time frame: 4 weeks
Postoperative clinical evaluation of the surgical site including signs of inflammation, infection, or intraoral wound dehiscence.
2 secondary outcomes
Prosthetic Survival
Time frame: 1 year
Oral Health Impact Profile (OHIP-14)
Time frame: 1 year
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 11 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be shared outside the study team.
Related trials for Maxillary Defect Reconstruction
Not yet recruitingObservational study
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
Maxillary Obturators, Maxillary Defect Reconstruction
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.
Eslam A Gharieb principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zygomatic implant installation using custamized bone supported surgical guide in people with Maxillary Defect Reconstruction and Atrophic Edentulous Maxilla, run by Tanta 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 3 inclusion and 2 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 11 Mar 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?
implant success. (time frame: 3 months). The study lists 6 primary outcomes in all. 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 11 Mar 2026.