NCT06963242 Evaluating the Accuracy of Dynamic Navigation in Implant Surgery for Full Arch Prosthesis

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This trial targets 12 participants in total. It began in 2024-07-01 with a primary completion date of 2025-08-31.

Brief Summary

Study Objective: This study aims to evaluate the accuracy of the Dynamic Navigation System in performing implant placement for full arch prosthesis rehabilitation. This system uses landmarks, including bone screws fixed to the bone (Group 1), and landmarks on remaining teeth to be extracted (Group 2), to accurately determine the placement of the implants Participants: Patients aged 18 and older, who have total tooth loss or partial tooth loss, and are candidates for full arch implant-supported prosthesis rehabilitation, are invited to participate, provided they meet the necessary health requirements for surgery. Group 1: Patients who have total tooth loss or partial tooth loss but do not meet the following conditions: 1. Having at least 3 remaining teeth or roots with mobility no greater than grade 1, and 2. The remaining teeth are distributed with at least 1 tooth in the front and 1 tooth in the back on each side of the arch. These patients will have bone screws placed on the bone to serve as landmarks for implant placement using the dynamic navigation system. Group 2: Patients who have at least 3 remaining teeth, all with mobility no greater than grade 1, and at least one tooth in the front and one in the back on each side of the arch. These teeth will serve as landmarks for implant placement. Study Methodology: Group 1: Patients who have total or partial tooth loss, and do not meet the conditions of having at least 3 remaining teeth with mobility no greater than grade 1, and having at least one tooth in the front and one in the back on each side, will have bone screws placed on the bone as landmarks for implant placement. Group 2: Patients with at least 3 remaining teeth with mobility no greater than grade 1, and at least one tooth in the front and one in the back on each side, will use these teeth as landmarks for implant placement. After surgery, the implant deviation from the planned implant data will be evaluated to assess the accuracy of implant placement. Factors such as implant position deviation, surgery time, and complications will be evaluated to compare the effectiveness between the two groups. Benefits and Risks: 1. Benefits: 1. Improved accuracy in implant placement using the Dynamic Navigation System. 2. Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study. 3. Scientific contribution to improving implant placement methods for future patients. 2. Risks: 1. Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system. 2. Radiation exposure from imaging tests, particularly CBCT scans, will be required. The radiation exposure is minimal and within safe limits. 3. Slight increase in surgery time, typically 2-5 minutes longer than traditional surgery, for preparation and calibration of the navigation system to ensure its proper functionality. 4. For Group 1 participants, bone screws (4-6 screws) will be placed along the jaw arch where the implants are to be positioned.

Eligibility Criteria

Inclusion Criteria: * Patients who are fully edentulous or have partial edentulism and are in need of full arch prosthesis rehabilitation. * Aged 18 years and older. * Individuals in good general health (American Society of Anesthesiologists (ASA) class I or II) * Willing to participate in the study and provide informed consent. Exclusion Criteria: * Any serious medical (ASA class III or IV) or psychiatric conditions. * Pregnant or breastfeeding women. * General or Local Health Conditions Affecting Surgery: Systemic/local conditions that affect surgical healing, wound healing, and bone integration or use of medications such as steroids, bisphosphonates, or other drugs affecting bone health; smoking more than 10 cigarettes per day; acute infections at the planned implant site that have not been treated. * Patients with a limited mouth opening of less than 40mm.

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