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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:
Clinical Study:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-arch dental implant treatment with dynamic navigation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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). | 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. | 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). | From enrollment to the end of surgery (second CBCT) |
| Angular Deviation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lam Tan Bui, MSc | Contact | +84928546291 | buitanlam@ump.edu.vn | |
| Loan Thi Huong Pham, PhD | Contact | +84918279595 | phamthuongloan@ump.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Lam Tan Bui, MSc | Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Recruiting | Ho Chi Minh City | 70000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38893060 | Background | Nunes M, de Araujo Nobre M, Camargo V. All-on-4 Hybrid with Extra-Long Transnasal Implants: Descriptions of the Technique and Short-Term Outcomes in Three Cases. J Clin Med. 2024 Jun 6;13(11):3348. doi: 10.3390/jcm13113348. | |
| 34386227 | Background | Almeida PHT, Cacciacane SH, Arcazas Junior A. Extra-long transnasal implants as alternative for Quad Zygoma: Case report. Ann Med Surg (Lond). 2021 Jul 27;68:102635. doi: 10.1016/j.amsu.2021.102635. eCollection 2021 Aug. |
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We intend to share IPD regarding the deviation in implant positioning from planned data. No personally identifiable information (PII) will be shared.
May 2025 - February 2028
The IPD and supporting information will be accessible to researchers, regulatory bodies, and other authorized individuals involved in the study. Access will be granted to those who have received approval from the ethics committee or relevant regulatory authorities. These individuals will be able to access the data via a secure, password-protected portal or system provided by the study team. All users will be required to sign a data sharing agreement to ensure confidentiality and compliance with the relevant data protection regulations.
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|
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.
| From enrollment to the end of surgery (second CBCT) |
| 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. | From enrollment to the prosthetic stage (6 months post-surgery) |
| Torque value | This is evaluated using measures of torque (Ncm) values during placement. | In the surgery |
| 30693262 | Background | Singhal MK, Dandriyal R, Aggarwal A, Agarwal A, Yadav S, Baranwal P. Implant Placement into the Nasopalatine Foramen: Considerations from Anatomical and Surgical Point of View. Ann Maxillofac Surg. 2018 Jul-Dec;8(2):347-351. doi: 10.4103/ams.ams_161_17. |
| 21802186 | Background | Jensen OT, Cottam J, Ringeman J, Adams M. Trans-sinus dental implants, bone morphogenetic protein 2, and immediate function for all-on-4 treatment of severe maxillary atrophy. J Oral Maxillofac Surg. 2012 Jan;70(1):141-8. doi: 10.1016/j.joms.2011.03.045. Epub 2011 Jul 28. |
| 39270594 | Background | Pena-Cardelles JF, Markovic J, De Souza A, Hamilton A, Lanis A, Gallucci GO. Survival, Success, and Neuropathic Alterations Related to Implant Placement Procedures in the Nasopalatine Canal: A Systematic Review and Meta-analysis. Int J Periodontics Restorative Dent. 2025 Nov 7;45(6):805-811. doi: 10.11607/prd.7168. |
| 30947851 | Background | Nicoli G, Piva S, Ferraris P, Nicoli F, Jensen OT. Extra-Long Nasal Wall-Directed Dental Implants for Maxillary Complete Arch Immediate Function: A Pilot Study. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):349-356. doi: 10.1016/j.coms.2019.01.004. |
| 24179981 | Background | Malo P, Nobre Md, Lopes A. Immediate loading of 'All-on-4' maxillary prostheses using trans-sinus tilted implants without sinus bone grafting: a retrospective study reporting the 3-year outcome. Eur J Oral Implantol. 2013 Autumn;6(3):273-83. |
| 31090746 | Background | Grandi T, Faustini F, Casotto F, Samarani R, Svezia L, Radano P. Immediate fixed rehabilitation of severe maxillary atrophies using trans-sinus tilted implants with or without sinus bone grafting: One-year results from a randomised controlled trial. Int J Oral Implantol (Berl). 2019;12(2):141-152. |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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