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CompletedNCT07912658Updated Nov 3, 2026

Comparing Resin and Metallic Surgical Guides for Zygomatic Implants in Patients With Severe Upper Jaw Bone Loss

An interventional study of resin guide group and metal guide group in Atrophic Maxilla, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2024, registered Oct 2026).
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Atrophic Maxilla

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Keywords

  • guided zygomatic implants
  • metallic surgical guide
  • resin surgical guide
  • static computer-assisted implant surgery
03

In context

Atrophic Maxilla

30 studies on the registry are indexed under Atrophic Maxilla; 11 are open to participants now.

This study's enrollment of 15 is close to the median of 16 across 27 interventional studies indexed under Atrophic Maxilla.

Browse Atrophic Maxilla studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    resin guide group

    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.

    Device: resin guide group

  • Active comparator
    metal guide group

    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.

    Device: metal guide group

Interventions

  • Deviceresin guide group

    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

  • Devicemetal guide group

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: two weeks

  2. 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

    Time frame: two weeks

  3. 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

    Time frame: 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.

    Time frame: up to four months after implant placement

07

Study locations

1 site
  • Cairo university
    Cairo, Egypt
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Jan 2026, 16 months.

Of 20 interventional studies with no phase under Atrophic Maxilla, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 32. This study's 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2026
First posted
Nov 3, 2026
StartActual
Sep 10, 2024
Primary completionActual
Jan 10, 2026
CompletionActual
Jun 23, 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07912658
Lead sponsor
Cairo University
Responsible party
Mohamed Ahmed Ahmed Hassan El Zahwy (principle investigator, Cairo University) — Principal investigator
First posted
Nov 3, 2026
Start date
Sep 10, 2024
Primary completion
Jan 10, 2026
Completion
Jun 23, 2026
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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