An interventional study of Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation in Atrophy of Edentulous Maxillary Alveolar Ridge and Alveolar Bone Atrophy, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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:
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.
Objectives:
Study Type: Clinical Trials Study. Study Period: From 2024 to 2027.
Study Locations:
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:
Exclusion Criteria:
Study Procedure:
Pre-surgery (Implant Placement):
During Surgery:
Post-surgery:
Exclusion Criteria:
This study involves placing three types of implants-nasopalatine, trans-sinus, and trans-nasal implants-using dynamic navigation in patients with complete maxillary edentulism and severe bone resorption. The primary goal is to assess the accuracy of implant placement and the clinical effectiveness of these implants for full-arch rehabilitation. Key measurements, such as 3D deviation, lateral and vertical linear deviation, and angular deviation, will be analyzed to compare the actual and planned implant positions. This study aims to evaluate the precision and success of dynamic navigation-assisted implant placement in patients with significant bone loss.
Procedure: Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation
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.
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.
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
Plan to share: Yes — We intend to share IPD regarding the deviation in implant positioning from planned data. No personally identifiable information (PII) will be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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University of Medicine and Pharmacy at Ho Chi Minh City