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
This study aims to explore the anatomical features of the anterior maxillary bone and then apply dynamic navigation technology for full-arch dental implant placement. The primary goal is to assess how dynamic navigation can improve the precision and success of implant placement in patients with complete edentulism or significant bone resorption in the upper jaw. 1. Objectives: * To analyze the anatomical features of the nasopalatine canal and the anterior sinus wall using CBCT imaging to guide full-arch implant placement. * To evaluate the accuracy of implant surgeries, including the placement of nasopalatine implants, trans-sinus implants, and trans-nasal implants, with the assistance of dynamic navigation systems. * To assess the clinical effectiveness of nasopalatine implants, trans-sinus implants, and trans-nasal implants in full-arch rehabilitation. * To investigate the correlation between the anatomical features of the nasal cavity and the anterior sinus wall on CBCT images and their influence on implant placement outcomes. 2. Clinical Study: Study Type: Clinical Trials Study. Study Period: From 2024 to 2027. Study Locations: * The Center of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City * Van Hanh General Hospital Sampling Method: Convenience sampling. Study Subjects: The study will involve a convenience sample of patients with complete or partial edentulism, who require tooth extraction and full-arch rehabilitation with implants. These patients will receive treatment at the Center of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City, and Van Hanh General Hospital from May 2025 to December 2027. Each patient may have multiple study units (implants) depending on the treatment plan. Inclusion Criteria: * Patients aged 18 years and above. * Good overall health (Class 1 and 2 according to the American Society of Anesthesiologists classification system). * Patients with complete edentulism of the upper jaw, classified as Class IV to VI according to Cawood and Howell. Exclusion Criteria: * Systemic or local conditions that may interfere with surgery, healing, or bone integration, such as cardiovascular diseases, diabetes, bone-related diseases, or medications affecting bone metabolism. * Patients who smoke more than 10 cigarettes per day or have untreated acute infections at the planned implant site. * Patients with a mouth opening limited to less than 40mm. Study Procedure: Pre-surgery (Implant Placement): * Clinical examination, panoramic radiography, fabrication of a film guide, and CBCT imaging with the film guide will be performed. * Based on CBCT data and the film guide, bone measurements will be taken, and a treatment plan will be created using virtual implants with appropriate positions and sizes. * 4-6 pilot holes will be placed for implant placement, adjusted to avoid critical anatomical structures like the maxillary sinus and inferior alveolar nerve. * Full blood count and coagulation tests will be conducted. During Surgery: * Implant surgery will be performed under local anesthesia or sedation. * An incision and full mucosal flap reflection will expose the implant site. * A clip will be secured to the anterior bone region of the maxilla using at least two screws. The clip will be connected to the handle and the patient monitoring device, which will be attached to the surgical drill. * The dynamic navigation system tool will be adjusted, and the synchronization of the system's landmarks will be performed. * Drilling and implant placement will be guided using the dynamic navigation system. * The primary stability of the implants will be measured. Depending on the stability, the implants will be connected to either a healing cap or multi-unit abutment. * Suturing will be performed. Post-surgery: * Post-operative CBCT imaging will be performed. * Post-operative care will include prescribed medications, cold compresses for the first day, and warm compresses starting from the second day after surgery. Gentle cleaning of the surgical site will be advised. Provisional restorations will be provided. * Follow-up visits will be scheduled on the 3rd, 7th, 14th, 1st month, 3rd month, and 6th month after surgery. Permanent restoration will be performed on the implants at the 6-month follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pre-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.
Faculty of Dentistry
Ho Chi Minh City, Vietnam
RECRUITINGBone-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.
Time frame: From enrollment to the end of surgery (second CBCT)
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).
Time frame: From enrollment to the end of surgery (second CBCT)
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).
Time frame: From enrollment to the end of surgery (second CBCT)
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.
Time frame: From enrollment to the end of surgery (second CBCT)
Vertical Linear Deviation
This measures the vertical distance between the planned and actual positions of the implant, assessing any deviation in the upward or downward direction along the Z axis (mm).
Time frame: From enrollment to the end of surgery (second CBCT)
Angular Deviation
This measures the angular (°) difference between the planned angle of the implant and the actual angle of the implant at the coronal or apical level. It helps assess how well the implant's rotation and orientation match the planned design.
Time frame: From enrollment to the end of surgery (second CBCT)
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.
Time frame: From enrollment to the prosthetic stage (6 months post-surgery)
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.
Time frame: From enrollment to the prosthetic stage (6 months post-surgery)
Torque value
This is evaluated using measures of torque (Ncm) values during placement.
Time frame: In the surgery
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