Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:15 AM
Study NCT ID:
NCT07463469
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Accuracy of Three-Dimensionally Guided Zygomatic Implant Installation
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Evaluation of the Accuracy of Three-Dimensionally Guided Zygomatic Implant Placement: A Prospective Clinical Study
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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:
1. 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
2. The DICOM images of the post-operative CT were uploaded in dedicated software.
3. Segmentation based on tissue density was carried out to separate implants from the surrounding bone.
4. The STL files of the maxillary bone with the planned implant positions obtained from the initial CT scan were uploaded into the software.
Superimposition
1. 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.
2. 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
1. The implant lengths By superimposition of the postoperative implant length onto the virtually planned implant length
2. 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
3. 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
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:
1. 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
2. The DICOM images of the post-operative CT were uploaded in dedicated software.
3. Segmentation based on tissue density was carried out to separate implants from the surrounding bone.
4. The STL files of the maxillary bone with the planned implant positions obtained from the initial CT scan were uploaded into the software.
Superimposition
1. 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.
2. 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
1. The implant lengths By superimposition of the postoperative implant length onto the virtually planned implant length
2. 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
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: