Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

Launched by SHANGHAI NINTH PEOPLE'S HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIVERSITY · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for placing dental implants in patients who have lost all their teeth, a condition known as being edentulous. The researchers want to find out which method is more accurate: using a static template (a fixed guide for placement) or dynamic navigation (a real-time guidance system during the procedure). The trial involves multiple centers and participants will be randomly assigned to one of the two groups.

To be eligible for this study, participants need to be at least 18 years old, in good health (specifically, ASA Levels 1 and 2), and have specific conditions regarding their dental situation, such as being completely edentulous or having very few remaining teeth. The study will assess the accuracy of implant placement, and participants can expect to receive implant-supported restorations that will improve their ability to chew and enhance their smile. Importantly, individuals with certain health issues, acute dental problems, or who smoke heavily will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years old and above
• • American society of anesthesiologists (ASA) Levels 1 and 2
• * Satisfy any of the following requirements:
• • 1. Edentulous maxillary patients
• • 2. Edentulous mandibular patients
• • 3. Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
• • 4. Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
• • 5. Full-mouth edentulous patients
• • 6. Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
• • Implant-supported fixed restorations or implant-supported overdenture restorations
• • Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
• • Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
• • Mouth opening of 3 fingers or more
• • Single-jawed missing patients treated with systemic periodontal therapy
• Exclusion Criteria:
• • Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
• • ASA grades 3 and 4
• • Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \> 4 mm) and untreated acute and chronic apical periodontitis
• • Pregnancy or breastfeeding
• • History of radiotherapy to the head and neck
• • Heavy smokers (more than 10 cigarettes per day)
• • Restricted mouth opening (less than three fingers).
• • Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).