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

Last updated: May 8, 2025
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

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

Clinical Study ID

NCT06974253
25213-DHYD
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older

  • Good overall health (Class 1 and 2 according to the American Society ofAnesthesiologists classification system)

  • Clinical diagnosis of complete edentulism of the upper arch classified as Class IVto VI according to Cawood and Howell

Exclusion

Exclusion Criteria:

  • Systemic or local conditions that may affect surgery, wound healing, or boneintegration, such as cardiovascular diseases, diabetes, bone-related diseases, ormedication 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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Nasopalatine Implants, Trans-Sinus Implants, and Trans-Nasal Implants for Full-Arch Rehabilitation
Phase:
Study Start date:
May 30, 2025
Estimated Completion Date:
February 29, 2028

Study 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.

  1. 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.

  2. 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.

Connect with a study center

  • Faculty of Dentistry

    Ho Chi Minh City, 70000
    Vietnam

    Active - Recruiting

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