NCT Number: NCT07551024
Some patients lose a large amount of bone in the upper jaw. When this happens, it can be difficult to place regular dental implants. In these cases, special implants called zygomatic implants can be used. These implants are longer than normal implants and are fixed in the cheekbone, which usually has enough bone to support them. They can help support fixed teeth for patients with severe bone loss in the upper jaw.
Placing zygomatic implants requires careful planning and high accuracy. To help guide the surgeon during the operation, a surgical guide can be used. A surgical guide is a custom-made device that helps the surgeon place the implant in the planned position.
Surgical guides can be made from different materials. The most common type is made from resin (a strong plastic material) using 3D printing. Recently, fully metallic surgical guides have been developed. These metal guides may be stronger and more stable during surgery, but it is not yet clear if they improve the accuracy of implant placement.
The purpose of this study is to compare the accuracy of metal surgical guides and resin surgical guides when placing zygomatic implants in patients with severe bone loss in the upper jaw.
Patients included in the study will undergo a clinical examination and a CT scan before surgery to plan the implant positions. During the surgery, each patient will receive zygomatic implants on both sides of the upper jaw. On one side, the implants will be placed using a metal surgical guide, and on the other side, they will be placed using a resin surgical guide. This allows the two types of guides to be compared in the same patient.
After the surgery, another CT scan will be taken to check the final position of the implants. The planned implant position will be compared with the actual position after surgery to measure the accuracy of placement.
The results of this study will help determine whether metallic surgical guides or resin surgical guides provide better accuracy when placing zygomatic implants.
Participation in this study is voluntary. All patients will receive full information about the study and will sign a consent form before participating.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Cairo, Cairo Governorate, 11835, Egypt
Location status: Recruiting
lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor
CONTACT
omar magdy elawady, Bachelor
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Before surgery, a CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement.
On the assigned side, the zygomatic implant will be placed using this resin guide.
CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. , the zygomatic implant will be placed using this metallic guide on one side.
Time frame: from enrolment to the implant placement at 4 weeks
Measured by deviation (mm, degrees) between planned and placed implant positions (CT superimposition) using computer software Using Real Guide. on each side for assessment for accuracy of implant placement in each group
Time frame: from time of enrolment to time of surgery 2 weeks
the primary stability is assessed after implant placement at time of surgery using osstell in ISQ
Time frame: from enrolment to the time of surgery 2 weeks
This outcome assesses any adverse events or procedural difficulties occurring during zygomatic implant placement. Examples include:
Excessive bleeding beyond normal surgical expectations Damage to adjacent anatomical structures (e.g., infraorbital nerve, orbital floor ) Fracture or deformation of the surgical guide during the procedure Difficulties in achieving planned implant trajectory or insertion Any other unanticipated events affecting the safety or conduct of the surgery All intraoperative complications will be documented by the operating surgeon in real time
Time frame: measured intraoperatively during surgery in minutes
This outcome measures the duration of the zygomatic implant placement procedure. Surgical time is defined as the time from the initial incision to the completion of implant placement and suture closure Time will be recorded in minutes using a standard surgical timer This outcome helps determine whether the type of surgical guide affects the operative workflow and efficiency
Contact information is provided by the study sponsor or research team.
ahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor
CONTACT
00201012162020 ext. 00201012162020
aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
CONTACT
Future University in Egypt
Other
Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Surgical Guides in Severely Atrophic Maxilla.
Acronym: guided surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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