Accuracy and Primary Stability of Straight and Tapered Implants in Immediate Implant Placement Using Dynamic Navigation

Study Overview
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Brief Summary
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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 a reported better implant positioning. There are two main choices of implant macrogeometry: straight and tapered implants. One feature of implant design that may influence implants' accuracy is the taper of the implant body. However, their exact role is still needed to be investigated further. Besides, implant macrogeometry may influence primary stability, which is a prerequisite in achieving osseointegration. Therefore, we designed a randomized controlled clinical trial study to verify the clinical efficacy of the implant macrogeometry by comparing straight implants with tapered implants in immediate implant placement using dynamic navigation.

Official Title
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Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets Using Dynamic Navigation

Conditions
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Tooth Diseases

Intervention / Treatment
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* Procedure: Tapered Implants
* Procedure: Straight Implants


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

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 |
| --- | --- |
| Active Comparator: tapered implant<br> | Procedure: Tapered Implants<br>* Tapered Implants are placed in fresh socket via dynamic navigation<br>|
| Placebo Comparator: straight implant<br> | Procedure: Straight Implants<br>* Straight Implants are placed in fresh socket via dynamic navigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | mm | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insetion torque value, ITV | to detect primary stability | surgery day | 
| Implant Stability Quotient, ISQ | to detect primary stability | surgery day |