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.