Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading

Study Overview
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Brief Summary
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Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. The study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.

Official Title
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Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading

Conditions
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Single Missing Tooth Rehabilitation

Intervention / Treatment
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* Device: x-guide dynamic navigation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 to 80 years old Miss two functional opposing teeth in one quadrant or the same jaw The situation of oral tissue satisfies the condition of implant immediate loading. Exclusion Criteria: catastrophic illness, diabetes, cardiovascular diseases, osteoporosis, head and neck cancer, disabled pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dynamic navigation group or static guide group<br>Every patient has 2 missing in one jaw The missing tooth will be restored with one-visit single implant immediate loading. One implant placed is assisted with dynamic navigation system, and the other one is assisted with static surgical guide. | Device: x-guide dynamic navigation system<br>* One implant placement is assisted with x-guide dynamic navigation system. The other implant placement is assisted with static surgical guide<br>* Other names: static surgical guide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record visiting time | Record the time (minutes) in every clinical procedure | during procedure | 
| Implant success rate | No osteointegration of implant | Change in periapical film of the implant on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year | 
| Prosthesis success rate | Morphology of the restoration | Change in photo on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year | 
| surgical complications | pain, swelling, infection after surgery | Post operation 1 week | 
| prosthetic success rates | final pink aesthetic score | Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year | 
| Implant stability quotient (ISQ) | implant stability | Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of incision | flap or flapless | during the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital workflow, one-visit single-implant immediate loading, dynamic navigation, Single missing tooth, static surgical guide