Dental ImplantsNCT06925438
"Computer-Guided vs Freehand Zygomatic Implant Placement
A study testing Computer-guided zygomatic implant system and free-hand zygomatic implant placement in people with Dental Implants and Maxillary Diseases, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
This randomized trial compares computer-guided versus free-hand zygomatic implant placement in patients with atrophic maxillae or maxillary defects. Participants receive either 3D-navigated implants (using stereolithographic guides) or conventional free-hand placement. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dental Implants, Maxillary Diseases
- What is being tested?
- Computer-guided zygomatic implant system and free-hand zygomatic implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Jan 2023to 12 Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥40 years
- Atrophic maxillary ridge (Cawood \& Howell Class IV-VI)
- Maxillary defects due to trauma, tumor resection, or congenital conditions
Who cannot join
- Acute maxillary sinusitis
- Uncontrolled systemic diseases affecting osseointegration
- Pathological lesions in maxilla/zygoma
- Heavy smoking (>20 cigarettes/day)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dental Medicine - Boys, Al-Azhar University
Cairo, Cairo Governorate, 11651
Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine - Boys, Al-Azhar University
Cairo, Cairo Governorate, 11651
About this study
Official title: Comparison Between Computer Guided and Free Hand Placement of Zygomatic Implants (Clinical and Radiographic Evaluation)
This randomized trial compares computer-guided versus free-hand zygomatic implant placement in patients with atrophic maxillae or maxillary defects. Participants receive either 3D-navigated implants (using stereolithographic guides) or conventional free-hand placement. Primary outcomes measure accuracy through apical angular deviation (°), apical/coronal linear deviations (mm) relative to MSP/FHP/CP planes (CT-based), while secondary outcomes assess implant stability (ISQ) and complications (sinusitis/infection) over 6 months. The study evaluates whether guided surgery improves precision in complex maxillary rehabilitation.
Read the detailed description
"This study was retrospectively registered due to initial lack of awareness of prospective registration requirements. All procedures followed ethical guidelines (Approval #880/62), and results are reported transparently."
Study Design
A single-center, randomized controlled trial conducted at Al-Azhar University, comparing computer-guided versus free-hand zygomatic implant placement. Participants are allocated 1:1 to:
Group A (Free-hand): Implants placed using ZAGA classification with conventional surgical techniques.
Group B (Guided): Implants placed via 3D-printed bone-supported surgical templates (DICOM-based planning).
Interventions
Both Groups:
Pre-op: CT scans for zygomatic bone assessment.
Anesthesia: General anesthesia with local infiltration for hemostasis.
Surgical Protocol: Full-thickness flap, implant placement , two-stage healing.
Group B-Specific Steps:
Digital implant path planning (entrance/exit points).
Stereolithographic guide fabrication with metal sleeves.
Guide fixation with monocortical screws during surgery.
Rationale Zygomatic implants require high precision due to anatomical complexity. While free-hand placement depends on surgeon skill, computer guidance may reduce errors. This trial evaluates whether guided surgery improves accuracy (angular deviation) and reduces complications (sinusitis, infection).
Methodological Rigor Randomization: Block randomization via SPSS.
Blinding: Radiographic assessors blinded to group allocation.
Sample Size: 16 implants (8/group), powered to detect 3.73° mean angular deviation difference (α=0.05, β=0.10; based on Grecchi et al. 2022).
Ethical Compliance Approved by Al-Azhar University (Ref: 880/62).
Consent forms documented risks/benefits (e.g., sinus perforation, infection).
- Conditions
- Dental Implants, Maxillary Diseases
- Being tested
- Computer-guided zygomatic implant system, free-hand zygomatic implant placement
- Keywords
- "Zygomatic implants", "Atrophic maxilla rehabilitation", "Guided implant surgery", "Free-hand dental implantation", "3D-printed surgical guides"
- Medical subject headings
- Maxillary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-guided zygomatic implant systemProcedure or surgery
Preoperative digital planning (DICOM data) to fabricate guides with metal sleeves for drill alignment
free-hand zygomatic implant placementProcedure or surgery
Standard placement using sequential drills (2.8-3.6mm) under saline irrigation
| Study group | Role | What they receive |
|---|---|---|
| Computer-Guided Zygomatic Implants | Active comparator | Zygomatic implants placed using 3D-printed bone-supported surgical guides created from preoperative CT scans. Receives: Procedure: Computer-guided zygomatic implant system |
| Free-Hand Zygomatic Implants | Placebo comparator | Zygomatic implants placed using anatomical landmarks (ZAGA classification) without surgical guides. Receives: Procedure: free-hand zygomatic implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation of zygomatic implants
Difference in degrees between planned (virtual) and actual post-operative implant position, measured at the apical point using superimposed CT scans
Measured: Measured immediately post-operatively (Day 0)
Apical linear deviation of zygomatic implants
Difference in millimeters between planned (virtual) and actual post-operative implant position at the apical point, measured using superimposed CT scans along three planes midsagittal plane (MSP) - Frankfort horizontal plane (FHP) - coronal plane (CP)
Measured: Measured immediately post-operatively (Day 0)
Coronal linear deviation of zygomatic implants
Difference in millimeters between planned and actual implant position at the coronal point (implant neck), measured using superimposed CT scans along three planes midsagittal plane (MSP) - Frankfort horizontal plane (FHP) - coronal plane (CP)
Measured: Measured immediately post-operatively (Day 0)
Secondary outcomes (2)
Implant stability quotient (ISQ)
Primary and secondary stability measured using Osstell Mentor device at implant placement and 6-month follow-up"
Measured: Immediately post-op and at 6 months
Postoperative complication rates
Incidence of sinusitis, infection, soft tissue dehiscence, and oroantral communication assessed clinically
Measured: Assessed at 1 week, 1 month, 3 months, and 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start10 Jan 2023
- Primary completion15 Jan 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelfattah Moawad Abdelfattah, Al-Azhar University
- Investigators
- Bahaa El-Din Abd Raboo, phd, Study director, Al-Azhar University, faculty of dentistry ,Oral & Maxillofacial Surgery DeptMohamed Abdel Akhar, PhD, Study director, Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery DeptAbdelfattah Moawad, BDS, MSc, Principal investigator, Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925438
- Sponsor's protocol ID
- ZygomaticRCT880/62
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with corresponding offer on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Computer Guided and Free Hand Placement of Zygomatic Implants (Clinical and Radiographic Evaluation)
- ClinicalTrials.gov ID
- NCT06925438
- Acronym / sponsor ID
- ZygomaticRCT880/62
- Conditions
- Dental Implants, Maxillary Diseases
- Keywords
- "Zygomatic implants", "Atrophic maxilla rehabilitation", "Guided implant surgery", "Free-hand dental implantation", "3D-printed surgical guides"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 13 Apr 2025 (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 randomized trial compares computer-guided versus free-hand zygomatic implant placement in patients with atrophic maxillae or maxillary defects. Participants receive either 3D-navigated implants (using stereolithographic guides) or conventional free-hand placement. Primary outcomes measure accuracy through apical angular deviation (°), apical/coronal linear deviations (mm) relative to MSP/FHP/CP planes (CT-based), while secondary outcomes assess implant stability (ISQ) and complications (sinusitis/infection) over 6 months. The study evaluates whether guided surgery improves precision in complex maxillary rehabilitation.
Detailed description
"This study was retrospectively registered due to initial lack of awareness of prospective registration requirements. All procedures followed ethical guidelines (Approval #880/62), and results are reported transparently."
Study Design
A single-center, randomized controlled trial conducted at Al-Azhar University, comparing computer-guided versus free-hand zygomatic implant placement. Participants are allocated 1:1 to:
Group A (Free-hand): Implants placed using ZAGA classification with conventional surgical techniques.
Group B (Guided): Implants placed via 3D-printed bone-supported surgical templates (DICOM-based planning).
Interventions
Both Groups:
Pre-op: CT scans for zygomatic bone assessment.
Anesthesia: General anesthesia with local infiltration for hemostasis.
Surgical Protocol: Full-thickness flap, implant placement , two-stage healing.
Group B-Specific Steps:
Digital implant path planning (entrance/exit points).
Stereolithographic guide fabrication with metal sleeves.
Guide fixation with monocortical screws during surgery.
Rationale Zygomatic implants require high precision due to anatomical complexity. While free-hand placement depends on surgeon skill, computer guidance may reduce errors. This trial evaluates whether guided surgery improves accuracy (angular deviation) and reduces complications (sinusitis, infection).
Methodological Rigor Randomization: Block randomization via SPSS.
Blinding: Radiographic assessors blinded to group allocation.
Sample Size: 16 implants (8/group), powered to detect 3.73° mean angular deviation difference (α=0.05, β=0.10; based on Grecchi et al. 2022).
Ethical Compliance Approved by Al-Azhar University (Ref: 880/62).
Consent forms documented risks/benefits (e.g., sinus perforation, infection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-Guided Zygomatic Implants | Active comparator | Procedure: Computer-guided zygomatic implant systemZygomatic implants placed using 3D-printed bone-supported surgical guides created from preoperative CT scans. |
| Free-Hand Zygomatic Implants | Placebo comparator | Procedure: free-hand zygomatic implant placementZygomatic implants placed using anatomical landmarks (ZAGA classification) without surgical guides. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥40 years
- Atrophic maxillary ridge (Cawood \& Howell Class IV-VI)
- Maxillary defects due to trauma, tumor resection, or congenital conditions
Key exclusion criteria (4 listed)
- Acute maxillary sinusitis
- Uncontrolled systemic diseases affecting osseointegration
- Pathological lesions in maxilla/zygoma
- Heavy smoking (>20 cigarettes/day)
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 |
|---|---|---|
| Computer-guided zygomatic implant systemPreoperative digital planning (DICOM data) to fabricate guides with metal sleeves for drill alignment | Procedure or surgery | Computer-Guided Zygomatic Implants |
| free-hand zygomatic implant placementStandard placement using sequential drills (2.8-3.6mm) under saline irrigation | Procedure or surgery | Free-Hand Zygomatic Implants |
Primary outcome
Angular deviation of zygomatic implants
Time frame: Measured immediately post-operatively (Day 0)
Difference in degrees between planned (virtual) and actual post-operative implant position, measured at the apical point using superimposed CT scans
Apical linear deviation of zygomatic implants
Time frame: Measured immediately post-operatively (Day 0)
Difference in millimeters between planned (virtual) and actual post-operative implant position at the apical point, measured using superimposed CT scans along three planes midsagittal plane (MSP) - Frankfort horizontal plane (FHP) - coronal plane (CP)
Coronal linear deviation of zygomatic implants
Time frame: Measured immediately post-operatively (Day 0)
Difference in millimeters between planned and actual implant position at the coronal point (implant neck), measured using superimposed CT scans along three planes midsagittal plane (MSP) - Frankfort horizontal plane (FHP) - coronal plane (CP)
2 secondary outcomes
Implant stability quotient (ISQ)
Time frame: Immediately post-op and at 6 months
Postoperative complication rates
Time frame: Assessed at 1 week, 1 month, 3 months, and 6 months post-op
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 16 Apr 2025.
- Individual participant dataSharing planned: No. Data is available with corresponding offer on reasonable request
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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.
Bahaa El-Din Abd Raboo, phd study director
Al-Azhar University, faculty of dentistry ,Oral & Maxillofacial Surgery Dept
Mohamed Abdel Akhar, PhD study director
Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept
Abdelfattah Moawad, BDS, MSc principal investigator
Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-guided zygomatic implant system and free-hand zygomatic implant placement in people with Dental Implants and Maxillary Diseases, run by Al-Azhar University at 2 sites 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 4 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 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Angular deviation of zygomatic implants (time frame: Measured immediately post-operatively (Day 0)). The study lists 3 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 16 Apr 2025.