Status:
UNKNOWN
Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Edentulous Jaw
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 centra...
Eligibility Criteria
Inclusion
- 18 years old and above
- American society of anesthesiologists (ASA) Levels 1 and 2
- Satisfy any of the following requirements:
- Edentulous maxillary patients
- Edentulous mandibular patients
- Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
- Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
- Full-mouth edentulous patients
- 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
- 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).
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06051266
Start Date
April 1 2023
End Date
December 31 2024
Last Update
September 22 2023
Active Locations (1)
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1
Shanghai Ninth People's Hospital
Shanghai, China