Atrophic MaxillaNCT07912658
Comparing Resin and Metallic Surgical Guides for Zygomatic Implants in Patients With Severe Upper Jaw Bone Loss
A study testing resin guide group and metal guide group in people with Atrophic Maxilla, run by Cairo University at 1 site in Egypt.
Trial summary
Oral rehabilitation with dental implants in patients with severely atrophic maxillae often presents significant surgical challenges. Guided implant placement has been introduced to improve the accuracy of three-dimensional implant positioning and reduce the risk of complications associated with complex anatomical… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Maxilla
- What is being tested?
- resin guide group and metal guide group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 23 Jun 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a severely atrophic edentulous maxilla (Cawood classes V, or VI) that could not be rehabilitated using other treatment options.
- Patients who had at least 8 mm vertical bone height in the anterior maxilla to allow installation of at least 2 conventional implants
Who cannot join
- Patients with systemic diseases that might interfere with dental implant placement and/or osseointegration, such as uncontrolled diabetes, hypertension, or osteoporosis.
- Heavy smokers (>20 cigarettes per day) and patients with parafunctional habits, such as clenching or bruxism.
- Patients with pathological lesions involving the maxilla, maxillary sinus, or zygoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Accuracy for Zygomatic Implant Placement Using Resin Versus Metallic Stackable Patient Specific Surgical Guides for Rehabilitation of Severely Atrophic Maxilla: A Split Mouth Study
Oral rehabilitation with dental implants in patients with severely atrophic maxillae often presents significant surgical challenges. Guided implant placement has been introduced to improve the accuracy of three-dimensional implant positioning and reduce the risk of complications associated with complex anatomical structures.
This prospective split-mouth clinical study aimed to compare the accuracy of zygomatic implant placement using two different materials for patient-specific stackable surgical guides: resin and metal.
Read more
Fifteen patients requiring bilateral zygomatic implant placement were included in the study. Each patient received a metallic surgical guide on one side and a resin surgical guide on the contralateral side.
Patient-specific surgical guides were designed using preoperative computed tomography (CT) data and three-dimensional virtual implant planning. Postoperative CT images were registered with the preoperative plans to evaluate deviations between the planned and actual implant positions.
Implant placement accuracy was assessed by measuring coronal, apical, and angular deviations. The study aimed to evaluate the influence of surgical guide material on the accuracy of guided zygomatic implant placement.
Read the detailed description
Preoperative Preparation
All patients underwent implant placement surgery under general anesthesia following appropriate preoperative preparation and investigations.
Preoperative investigations included:
- Complete blood count (CBC).
- Liver function tests.
- Kidney function tests.
- Blood glucose level.
- Coagulation profile. All patients were provided with copies of their investigation results and were informed about the potential risks and complications associated with general anesthesia.
Flap Design and Reflection
A paracrestal palatal incision extending bilaterally from the maxillary tuberosities was performed.
The mucoperiosteal flap was reflected to expose the lateral wall of the maxillary sinus and the zygomatic process, extending superiorly toward the infraorbital foramen and posteriorly to expose the zygomatic bone.
Surgical Guide Stabilization
The patient-specific surgical guides were stabilized using miniscrews fixed to the exposed maxillary buttress to guide implant positioning, angulation, and drilling depth.
Zygomatic Implant Placement
Implant osteotomies were performed using two sequential zygomatic drills through the prefabricated surgical drilling guides.
The implants were transferred to the prepared osteotomy sites using their fixture mounts and manually inserted until their apical ends reached the planned positions within the zygomatic bone.
The fixture mounts were then removed. After confirming implant stability, cover screws were placed and secured.
Postoperative Instructions
All patients received written postoperative instructions and prescriptions for their postoperative medications.
- Conditions
- Atrophic Maxilla
- Being tested
- resin guide group, metal guide group
- Keywords
- guided zygomatic implants, metallic surgical guide, resin surgical guide, static computer-assisted implant surgery
- 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 guide groupDevice
Paracrestal palatal incision extend bilaterally from tuberosities will be performed.
The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. resin Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the implant is placed in the best location. Zygomatic implants
metal guide groupDevice
Paracrestal palatal incision extend bilaterally from tuberosities will be performed.
The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. Metal Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the implant is placed in the best location. Zygomatic implants
| Study group | Role | What they receive |
|---|---|---|
| resin guide group | Active comparator | Paracrestal palatal incision extend bilaterally from tuberosities will be performed.
The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. resin Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the zygomatic implant is placed in the best location. Receives: Device: resin guide group |
| metal guide group | Active comparator | Paracrestal palatal incision extend bilaterally from tuberosities will be performed.
The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. metal Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the zygomatic implant is placed in the best location. Receives: Device: metal guide group |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronal deviation of zygomatic implant placement measured using CT ( mm)
coronal deviation was measured in millimeter as linear distance between planned and actual coronal positions of zygomatic implant.
measurements were obtained by comparing the preoperative virtual plan with the postoperative CT scan using image registration. Lower deviation value indicate greater implant placement accuracy
Measured: two weeks
apical deviation of zygomatic implant placement measured using CT ( mm)
apical deviation was measured in millimeter as linear distance between planned and actual apical positions of zygomatic implant.
measurements were obtained by comparing the preoperative virtual plan with the postoperative CT scan using image registration. Lower deviation value indicate greater implant placement accuracy
Measured: two weeks
angular deviation of zygomatic implant placement measured using CT ( degrees)
angular deviation was measured in degrees as the angle between the planned and actual long axis of the zygomatic implant. measurements were obtained by comparing the preoperative virtual implant plan with the postoperative CT scan using the image registration , lower angular deviation value indicate greater implant placement accuracy
Measured: two weeks
Secondary outcomes (1)
Rate of postoperative biological complications
Postoperative complications were assessed through clinical examination and postoperative computed tomography (CT) imaging, as appropriate to each complication, during the first four months following zygomatic implant placement. Clinical and radiographic findings were recorded to identify postoperative complications, including sinusitis, sensory disturbances, and implant-related complications. Patients who developed complications received additional follow-up until clinical resolution.
Measured: up to four 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 posted3 Nov 2026
- Study start10 Sep 2024
- Primary completion10 Jan 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic MaxillaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between the accuracy of 2 different materials of surgical guides used with zygomatic implant placement in posterior maxilla to ensure the placement in the pre planned position and reduce potential complicatio
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ahmed Hassan El Zahwy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912658
- Sponsor's protocol ID
- Omfs 3 3 5
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accuracy for Zygomatic Implant Placement Using Resin Versus Metallic Stackable Patient Specific Surgical Guides for Rehabilitation of Severely Atrophic Maxilla: A Split Mouth Study
- ClinicalTrials.gov ID
- NCT07912658
- Acronym / sponsor ID
- Omfs 3 3 5
- Conditions
- Atrophic Maxilla
- Keywords
- guided zygomatic implants, metallic surgical guide, resin surgical guide, static computer-assisted implant surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 3 Nov 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.
Oral rehabilitation with dental implants in patients with severely atrophic maxillae often presents significant surgical challenges. Guided implant placement has been introduced to improve the accuracy of three-dimensional implant positioning and reduce the risk of complications associated with complex anatomical structures.
This prospective split-mouth clinical study aimed to compare the accuracy of zygomatic implant placement using two different materials for patient-specific stackable surgical guides: resin and metal.
Fifteen patients requiring bilateral zygomatic implant placement were included in the study. Each patient received a metallic surgical guide on one side and a resin surgical guide on the contralateral side.
Patient-specific surgical guides were designed using preoperative computed tomography (CT) data and three-dimensional virtual implant planning. Postoperative CT images were registered with the preoperative plans to evaluate deviations between the planned and actual implant positions.
Implant placement accuracy was assessed by measuring coronal, apical, and angular deviations. The study aimed to evaluate the influence of surgical guide material on the accuracy of guided zygomatic implant placement.
Detailed description
Preoperative Preparation
All patients underwent implant placement surgery under general anesthesia following appropriate preoperative preparation and investigations.
Preoperative investigations included:
- Complete blood count (CBC).
- Liver function tests.
- Kidney function tests.
- Blood glucose level.
- Coagulation profile. All patients were provided with copies of their investigation results and were informed about the potential risks and complications associated with general anesthesia.
Flap Design and Reflection
A paracrestal palatal incision extending bilaterally from the maxillary tuberosities was performed.
The mucoperiosteal flap was reflected to expose the lateral wall of the maxillary sinus and the zygomatic process, extending superiorly toward the infraorbital foramen and posteriorly to expose the zygomatic bone.
Surgical Guide Stabilization
The patient-specific surgical guides were stabilized using miniscrews fixed to the exposed maxillary buttress to guide implant positioning, angulation, and drilling depth.
Zygomatic Implant Placement
Implant osteotomies were performed using two sequential zygomatic drills through the prefabricated surgical drilling guides.
The implants were transferred to the prepared osteotomy sites using their fixture mounts and manually inserted until their apical ends reached the planned positions within the zygomatic bone.
The fixture mounts were then removed. After confirming implant stability, cover screws were placed and secured.
Postoperative Instructions
All patients received written postoperative instructions and prescriptions for their postoperative medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- comparison between the accuracy of 2 different materials of surgical guides used with zygomatic implant placement in posterior maxilla to ensure the placement in the pre planned position and reduce potential complicatio
| Arm | Type | Receives |
|---|---|---|
| resin guide group | Active comparator | Device: resin guide groupParacrestal palatal incision extend bilaterally from tuberosities will be performed. The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. resin Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the zygomatic implant is placed in the best location. |
| metal guide group | Active comparator | Device: metal guide groupParacrestal palatal incision extend bilaterally from tuberosities will be performed. The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. metal Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the zygomatic implant is placed in the best location. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a severely atrophic edentulous maxilla (Cawood classes V, or VI) that could not be rehabilitated using other treatment options.
- Patients who had at least 8 mm vertical bone height in the anterior maxilla to allow installation of at least 2 conventional implants
Key exclusion criteria (3 listed)
- Patients with systemic diseases that might interfere with dental implant placement and/or osseointegration, such as uncontrolled diabetes, hypertension, or osteoporosis.
- Heavy smokers (>20 cigarettes per day) and patients with parafunctional habits, such as clenching or bruxism.
- Patients with pathological lesions involving the maxilla, maxillary sinus, or zygoma.
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 guide groupParacrestal palatal incision extend bilaterally from tuberosities will be performed. The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. resin Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the implant is placed in the best location. Zygomatic implants | Device | resin guide group |
| metal guide groupParacrestal palatal incision extend bilaterally from tuberosities will be performed. The flap will be reflected to expose the lateral wall of the maxillary sinus as well as the zygomatic process anteriorly inferiorly and superiorly up to infraorbital foramen and its posterior border the flap will be retracted from the superior border of zygoma. Metal Guides with be stabilized using mini screws on the exposed maxillary buttress to guide the implant direction and depth to ensure that the implant is placed in the best location. Zygomatic implants | Device | metal guide group |
Primary outcome
coronal deviation of zygomatic implant placement measured using CT ( mm)
Time frame: two weeks
coronal deviation was measured in millimeter as linear distance between planned and actual coronal positions of zygomatic implant. measurements were obtained by comparing the preoperative virtual plan with the postoperative CT scan using image registration. Lower deviation value indicate greater implant placement accuracy
apical deviation of zygomatic implant placement measured using CT ( mm)
Time frame: two weeks
apical deviation was measured in millimeter as linear distance between planned and actual apical positions of zygomatic implant. measurements were obtained by comparing the preoperative virtual plan with the postoperative CT scan using image registration. Lower deviation value indicate greater implant placement accuracy
angular deviation of zygomatic implant placement measured using CT ( degrees)
Time frame: two weeks
angular deviation was measured in degrees as the angle between the planned and actual long axis of the zygomatic implant. measurements were obtained by comparing the preoperative virtual implant plan with the postoperative CT scan using the image registration , lower angular deviation value indicate greater implant placement accuracy
1 secondary outcome
Rate of postoperative biological complications
Time frame: up to four months after implant placement
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 3 Nov 2026.
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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 resin guide group and metal guide group in people with Atrophic Maxilla, run by Cairo 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 2 inclusion and 3 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 3 Nov 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?
coronal deviation of zygomatic implant placement measured using CT ( mm) (time frame: two weeks). 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 3 Nov 2026.