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

Официальное название

Morphological Characteristics of Anterior Maxillary Anchorage Sites and Application of Dynamic Navigation in Full-Arch Dental Implant Placement

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Bone-to-implant contact [Срок оценки: From enrollment to the end of surgery (second CBCT)]
• 3D Deviation at Apex [Срок оценки: From enrollment to the end of surgery (second CBCT)]
• 3D Deviation at Coronal [Срок оценки: From enrollment to the end of surgery (second CBCT)]
• Lateral Linear Deviation [Срок оценки: From enrollment to the end of surgery (second CBCT)]
• Vertical Linear Deviation [Срок оценки: From enrollment to the end of surgery (second CBCT)]
• Angular Deviation [Срок оценки: From enrollment to the end of surgery (second CBCT)]

Вторичные конечные точки (3)

• Implant Survival Rate at 6 months post-surgeryy [Срок оценки: From enrollment to the prosthetic stage (6 months post-surgery)]
• Stability of Implant [Срок оценки: From enrollment to the prosthetic stage (6 months post-surgery)]
• Torque value [Срок оценки: In the surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Faculty of Dentistry — Ho Chi Minh City

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06974253 · 25213-DHYD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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