Faculty of Dentistry
Ho Chi Minh City, 70000, Vietnam
Location status: Recruiting
NCT Number: NCT06974253
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ho Chi Minh City, 70000, Vietnam
Location status: Recruiting
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.
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment to the end of surgery (second CBCT)
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)
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)
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)
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)
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)
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 prosthetic stage (6 months post-surgery)
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)
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: In the surgery
This is evaluated using measures of torque (Ncm) values during placement.
Contact information is provided by the study sponsor or research team.
Lam Tan Bui, MSc
CONTACT
Loan Thi Huong Pham, PhD
CONTACT
University of Medicine and Pharmacy at Ho Chi Minh City
Other
Morphological Characteristics of Anterior Maxillary Anchorage Sites and Application of Dynamic Navigation in Full-Arch Dental Implant Placement
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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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