Atrophy of Edentulous Maxillary Alveolar RidgeNCT06974253
Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement
A study testing Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation in people with Atrophy of Edentulous Maxillary Alveolar Ridge and Alveolar Bone Atrophy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophy of Edentulous Maxillary Alveolar Ridge, Alveolar Bone Atrophy
- What is being tested?
- Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteVietnam
- Study dates
- 30 May 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Ho Chi Minh City, 70000
Faculty of Dentistry, +842838558735, fos@ump.edu.vn
About this study
Official title: Morphological Characteristics of Anterior Maxillary Anchorage Sites and Application of Dynamic Navigation in Full-Arch Dental Implant Placement
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
Read the detailed description
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:
- 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.
- 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.
- Being tested
- Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation
- Keywords
- Nasopalatine Implant, Trans-sinus Implant, Trans-nasal Implant, Piriform Rim Implant
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch RehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From enrollment to the end of surgery (second CBCT)
Secondary outcomes (3)
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.
Measured: 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.
Measured: From enrollment to the prosthetic stage (6 months post-surgery)
Torque value
This is evaluated using measures of torque (Ncm) values during placement.
Measured: In the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start30 May 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atrophy of Edentulous Maxillary Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Tan Lam, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Lam Tan Bui, MSc, Principal investigator, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974253
- Sponsor's protocol ID
- 25213-DHYD
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to share IPD regarding the deviation in implant positioning from planned data. No personally identifiable information (PII) will be shared.
Publications
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.
PubMed 38893060Almeida 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.
PubMed 34386227Singhal 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.
PubMed 30693262Jensen 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.
PubMed 21802186Pena-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.
PubMed 39270594Nicoli 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.
PubMed 30947851Malo 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.
PubMed 24179981Grandi 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.
PubMed 31090746
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Characteristics of Anterior Maxillary Anchorage Sites and Application of Dynamic Navigation in Full-Arch Dental Implant Placement
- ClinicalTrials.gov ID
- NCT06974253
- Acronym / sponsor ID
- 25213-DHYD
- Keywords
- Nasopalatine Implant, Trans-sinus Implant, Trans-nasal Implant, Piriform Rim Implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-arch dental implant treatment with dynamic navigation | Experimental | Procedure: Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch RehabilitationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch RehabilitationPre-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. | Procedure or surgery | Full-arch dental implant treatment with dynamic navigation |
Primary outcome
Bone-to-implant contact
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.
3D Deviation at Apex
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).
3D Deviation at Coronal
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).
Lateral Linear Deviation
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.
Vertical Linear Deviation
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).
Angular Deviation
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.
3 secondary outcomes
Implant Survival Rate at 6 months post-surgeryy
Time frame: From enrollment to the prosthetic stage (6 months post-surgery)
Stability of Implant
Time frame: From enrollment to the prosthetic stage (6 months post-surgery)
Torque value
Time frame: In the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 38893060Nunes 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.
- Background: PubMed 34386227Almeida 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.
- Background: PubMed 30693262Singhal 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.
- Background: PubMed 21802186Jensen 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.
- Background: PubMed 39270594Pena-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.
- Background: PubMed 30947851Nicoli 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.
- Background: PubMed 24179981Malo 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.
- Background: PubMed 31090746Grandi 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.
- Individual participant dataSharing planned: Yes. We intend to share IPD regarding the deviation in implant positioning from planned data. No personally identifiable information (PII) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lam Tan Bui, MSc principal investigator
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation in people with Atrophy of Edentulous Maxillary Alveolar Ridge and Alveolar Bone Atrophy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lam Tan Bui, MSc (+84928546291, buitanlam@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone-to-implant contact (time frame: From enrollment to the end of surgery (second CBCT)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974253, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.