Clinical trial NCT06974253: Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement
Official title: Morphological Characteristics of Anterior Maxillary Anchorage Sites and Application of Dynamic Navigation in Full-Arch Dental Implant Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophy of Edentulous Maxillary Alveolar Ridge
Alveolar Bone Atrophy
Keywords: Nasopalatine Implant
Trans-sinus Implant
Trans-nasal Implant
Piriform Rim Implant
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bone-to-implant contact
timeFrame: From enrollment to the end of surgery (second CBCT)
measure: 3D Deviation at Apex
timeFrame: From enrollment to the end of surgery (second CBCT)
measure: 3D Deviation at Coronal
timeFrame: From enrollment to the end of surgery (second CBCT)
measure: Lateral Linear Deviation
timeFrame: From enrollment to the end of surgery (second CBCT)
measure: Vertical Linear Deviation
timeFrame: From enrollment to the end of surgery (second CBCT)
measure: Angular Deviation
timeFrame: From enrollment to the end of surgery (second CBCT)
Secondary outcomes:
measure: Implant Survival Rate at 6 months post-surgeryy
timeFrame: From enrollment to the prosthetic stage (6 months post-surgery)
measure: Stability of Implant
timeFrame: From enrollment to the prosthetic stage (6 months post-surgery)
measure: Torque value
timeFrame: In the surgery
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Dentistry
Study officials:
affiliation: Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
name: Lam Tan Bui, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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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citation: 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.
citation: 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. 2024 Sep 6:1-18. doi: 10.11607/prd.7168. Online ahead of print. No abstract available.
citation: 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.
citation: 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.
citation: 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.