Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Edentulous Jaw

Treatments

Device: Dynamic navigation

Device: Static template

Study type

Interventional

Funder types

Other

Identifiers

NCT06051266

SDC-23-2

Details and patient eligibility

About

The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.

Enrollment

58 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).