The goal of this clinical trial is to evaluate the effectiveness of dynamic navigation in full-arch dental implant placement in patients with complete maxillary edentulism. The main questions it aims to answer are:
* the accuracy of nasopalatine implants, trans-sinus implants, and trans-nasal implants placement in the anterior maxillary bone with dynamic navigation * the clinical effectiveness of nasopalatine implants, trans-sinus implants, and trans-nasal implants in full-arch rehabilitation * the correlation between the anatomical features of the nasal cavity and the anterior sinus wall on CBCT images and their influence on nasopalatine implants, trans-sinus implants, and trans-nasal implants position
Aged 18 years or older
Good overall health (Class 1 and 2 according to the American Society of Anesthesiologists classification system)
Clinical diagnosis of complete edentulism of the upper arch classified as Class IV to VI according to Cawood and Howell
Systemic or local conditions that may affect surgery, wound healing, or bone integration, such as cardiovascular diseases, diabetes, bone-related diseases, or medication affecting bone metabolism
Smoking more than 10 cigarettes per day
Presence of acute infections in the planned implant site
Limited mouth opening of less than 40mm
Single group
Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation
Procedure/SurgeryPre-surgery (Implant Placement): Clinical examination, panoramic radiography, film guide creation, and CBCT imaging will be performed. Based on CBCT data and the film guide, bone measurements will be taken, and a treatment plan with virtual implants will be developed. 4-6 pilot holes will be made, adjusting for critical structures like the maxillary sinus, inferior alveolar nerve, and planned implant sites. Full blood count and coagulation tests will be done. During Surgery: Implant surgery will be performed under local anesthesia/sedation. Incision and mucosal flap reflection will expose the implant site. A clip will be fixed to the anterior maxilla with screws, connected to the monitoring device. The dynamic navigation system will guide the placement of nasopalatine, trans-sinus, and trans-nasal implants, ensuring optimal placement. Post-surgery: Post-operative CBCT will be performed to check the implant positions, confirming the accuracy of the implant placement.
Bone-to-implant contact
Radiographs are analyzed to measure the bone level around the implant (mm). Bone-to-implant contact (BIC) is a crucial parameter used to evaluate the success and stability of dental implants.
3D Deviation at Apex
This measures the 3D deviation at the apex (bottom) of the implant site, which similarly involves assessing the horizontal and vertical position, along with depth, between the planned and actual implant positions at the tip of the implant (mm).
3D Deviation at Coronal
This measures the three-dimensional (3D) deviation between the planned implant position and the actual implant position at the coronal (top) aspect of the implant site (mm). It involves assessing discrepancies in the X, Y, and Z axes (horizontal, vertical, and depth).
Lateral Linear Deviation
This measures the horizontal distance (in the X or Y axis) between the planned implant position and the actual position (mm), specifically at the coronal or apical levels, and refers to any shift in the lateral direction.
Implant Survival Rate at 6 months post-surgeryy
Implant survival rate refers to the proportion of implants that remain in place without failure throughout the study period. An implant is considered to have survived if it remains functional, does not exhibit signs of failure (such as infection or implant loosening), and is not removed due to complications. The survival rate is typically measured as a percentage of implants that remain in place compared to the total number of implants placed. This measure provides a basic indication of the long-term effectiveness of the implant procedure.
Stability of Implant
Implant stability refers to the degree of primary and secondary integration between the implant and surrounding bone. This is evaluated using measures such as resonance frequency analysis during placement (ISQ). Primary stability occurs immediately after placement, while secondary stability refers to the osseointegration process during healing.
Torque value
This is evaluated using measures of torque (Ncm) values during placement.
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