Clinical trial NCT06051266: Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
Official title: Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Edentulous Jaw
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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).

Primary outcomes:
measure: Apical deviation of implant placement (mm)
timeFrame: About 3 days after surgery
Secondary outcomes:
measure: Coronal deviation of implant placement (mm)
timeFrame: About 3 days after surgery
measure: Angular deviation of implant placement (°)
timeFrame: About 3 days after surgery
measure: Operation time
timeFrame: Surgery day
measure: Implant stability quotient
timeFrame: Surgery day
measure: visual analogue scale
timeFrame: About 3 days after surgery
measure: Failure rate
timeFrame: About 4 months after surgery
measure: Change of marginal bone level(mm)
timeFrame: About 1 year after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Yiqun Wu
role: PRINCIPAL_INVESTIGATOR
References: