Accuracy of Dental Implant Placement, Atrophic Edentulous Maxilla, Dental Implant, Guided Surgery, Zygomatic Implants
Conditions
Keywords
Zygomatic implants, Severely atrophic maxilla, Surgical guides, Dental implant placement accuracy, Metal surgical guide, Resin surgical guide
Brief summary
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.
Interventions
DEVICEResin surgical Guide
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.
DEVICEGroup B (Metallic nickel 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.
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
each patient will receive zygomatic implants on both sides of the upper jaw, using two different types of surgical guides split mouth. Group A - Resin Surgical Guide: 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. Group B - Metallic Surgical Guide: The same CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. On the opposite side of the jaw, the zygomatic implant will be placed using this metallic guide. Both guides are used in the same surgery, one on each side of the upper jaw. This allows a direct comparison between the resin and metallic guides to see which one provides more accurate placement of the implants.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years with severely atrophic maxilla. * Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection. * Indicated for zygomatic implant-supported fixed prosthesis. * Sufficient mouth opening for zygomatic implants placement. * Patients willing to sign informed consent and attend follow-ups.
Exclusion criteria
* Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc). * Heavy smokers * Previous radiotherapy or bisphosphonate therapy. * Active sinus or nasal infection. * Severe parafunctional habits (e.g., bruxism). * Pregnant or lactating women. * Patients with psychiatric disorders affecting compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant placement accuracy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time | 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 |
| primary stability | 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 |
| Intraoperative Complications | 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 |
Countries
Egypt
Contacts
CONTACTahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor
CONTACTaya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
STUDY_CHAIRramy ragab el beialy, proffessor
cairo university in egypt
PRINCIPAL_INVESTIGATORmohamed safwat eid, bachelor
future unversity in egypt
Outcome results
None listed