Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 3, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedSeptember 22, 2023
August 1, 2023
9 months
September 3, 2023
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Apical deviation of implant placement (mm)
Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.
About 3 days after surgery
Secondary Outcomes (7)
Coronal deviation of implant placement (mm)
About 3 days after surgery
Angular deviation of implant placement (°)
About 3 days after surgery
Operation time
Surgery day
Implant stability quotient
Surgery day
visual analogue scale
About 3 days after surgery
- +2 more secondary outcomes
Study Arms (2)
Dynamic navigation
EXPERIMENTALStatic template
ACTIVE COMPARATORInterventions
Dynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery.
In most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures.
Eligibility Criteria
You may qualify if:
- 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)
- Mouth opening of 3 fingers or more
- Single-jawed missing patients treated with systemic periodontal therapy
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Ninth People's Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yiqun Wu
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2023
First Posted
September 22, 2023
Study Start
April 1, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
September 22, 2023
Record last verified: 2023-08