Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand

Study Overview
=================
Brief Summary
-----------------
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.

Detailed Description
-----------------
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters. These will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.

Official Title
-----------------
Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand

Conditions
-----------------
Tooth Diseases

Intervention / Treatment
-----------------
* Procedure: dynamic navigation surgery
* Procedure: freehand surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old and in good health; The maxillary incisor that cannot be retained due to non-periodontitis; The buccal bone plate is complete; No acute infection; The extraction socket have at least 3-5 mm apical bone. Exclusion Criteria: General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids); Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy); Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm; Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day); Refuse to participate in this trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>Dental implant placement using a dynamic navigation system | Procedure: dynamic navigation surgery<br>* immediate implant placement using dynamic navigation<br>|
| Sham Comparator: freehand<br>Dental implant placement using freehand technique | Procedure: freehand surgery<br>* immediate implant placement using freehand surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Taking cone-beam computed tomography (CBCT). The deviation between the planned implant and the actual implant were measured by Computer Assisted Dental Implant Precision System (Dcarer, Suzhou, China) as follows: (1) At least four feature points (like tooth cusps or bone pits) were selected in preoperative and postoperative CBCT for rough registration. (2) Feature surface circles in preoperative CBCT were selected, and then a mathematical algorithm displayed a similar feature surface circle in postoperative CBCT. The algorithm registered thousands of points in these two circles via conventional iso-surface thresholding technology. The software calculated registration error automatically. (3) Finally, the planned and actual implant were identified, and the deviation would be automatically calculated. | before surgery to after surgery one week | 
| Peri-implant soft tissue health | Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al. | 12-months follow-up after delivery of crown | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insetion torque value (ITV) | A general method to to detect primary stability roughly. The ITV were evaluated by a wrench (Straumann, Waldenburg, Switzerland) at the time of implant placement. The investigator record the number of scale. Being equal to or greater than 35N is a ideal primary stability. | surgery day | 
| Implant Stability Quotient (ISQ) | A device to detect primary stability precisely. A Smartpeg was screwed into each implant, and resonance frequency analysis (RFA) was performed using Osstell Mentor (Osstell/Integration Diagnostics, Goteborg, Sweden). ISQ were recorded in the buccal and the palatal directions three times and averaged. <60 represents low stability; 60-70 represents medium stability; higher than 70 represents high stability. | surgery day | 
| Esthetic appearance of the dental crown | PES-WES Score assessed using the Belser criteria | 12-months follow-up after delivery of the crown | 
| Patient satisfaction | Assessed using a visual analogue scale (VAS=100mm, with 0=completely dissatisfied and 100 completely satisfied). | 12-months follow-up after delivery of crown | 
| Peri-implant sulcus fluid Inflammation | Cytokine concentrations determined by multiplex ELISA | 12-months follow-up after delivery of crown | 
| Buccal bone changes | Measurements performed on post-operative CBCT taken for routine follow-up | 12-months follow-up after delivery of crown | 
| Implant microbiome | 16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point | 12-months follow-up after delivery of crown |