Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial

Conditions
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Edentulous Jaw

Intervention / Treatment
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* Device: Dynamic navigation
* Device: Static template


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic navigation<br> | Device: Dynamic navigation<br>* 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.<br>|
| Active Comparator: Static template<br> | Device: Static template<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronal deviation of implant placement (mm) | Preoperative planning and postoperative CBCT were aligned together in the software and coronal deviations(mm) of implant placement were measured to compare the results of the two groups. | About 3 days after surgery | 
| Angular deviation of implant placement (°) | Preoperative planning and postoperative CBCT were aligned together in the software and angular deviations(°) of implant placement were measured to compare the results of the two groups. | About 3 days after surgery | 
| Operation time | From anaesthesia to all implants are placed | Surgery day | 
| Implant stability quotient | Implant stability quotient was measured with the Osstell®device | Surgery day | 
| visual analogue scale | Patients were asked how they felt about the procedure using a visual analogue scale (VAS), which was measured using a visual analogue scale from 0 to 10. On a scale of 0 to 10 (no pain 0 to maximum pain 10) (very comfortable 0 to not at all comfortable 10) (no swelling 0 to severe swelling 10) | About 3 days after surgery | 
| Failure rate | Failure rate of implants during the healing period | About 4 months after surgery | 
| Change of marginal bone level(mm) | Marginal bone level = Measurement of the distance (mm) between the reference point (shoulder of the implant) and the point of bone-implant contact on the periapical film ; Change of marginal bone level = marginal bone level in the follow-up period - marginal bone level in the baseline period (mm) | About 1 year after surgery |