Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement

NCT06974253 | Recruiting DMC

• 1 other identifier: 25213-DHYD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Atrophy of Edentulous Maxillary Alveolar Ridge; Alveolar Bone Atrophy

Keywords

Nasopalatine Implant; Trans-sinus Implant; Trans-nasal Implant; Piriform Rim Implant

Outcome Measures

Primary Outcomes (6)

• 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

  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)

Secondary Outcomes (3)

• Implant Survival Rate at 6 months post-surgeryy

  From enrollment to the prosthetic stage (6 months post-surgery)

• Stability of Implant

  From enrollment to the prosthetic stage (6 months post-surgery)

• Torque value

  In the surgery

Study Arms (1)

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.

Procedure: Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation

Interventions

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.

Full-arch dental implant treatment with dynamic navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Dentistry

Ho Chi Minh City, 70000, Vietnam

RECRUITING

Related Publications (8)

• 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.

  PMID: 38893060 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.

  PMID: 34386227 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.

  PMID: 30693262 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.

  PMID: 21802186 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.

  PMID: 39270594 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.

  PMID: 30947851 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.

  PMID: 24179981 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.

  PMID: 31090746 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Lam Tan Bui, MSc

  Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lam Tan Bui, MSc

CONTACT

+84928546291; buitanlam@ump.edu.vn

Loan Thi Huong Pham, PhD

CONTACT

+84918279595; phamthuongloan@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 15, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: May 2025 - February 2028
• Access Criteria: 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.

Locations

VN (1)