Guided Surgery Versus Sinus Graft

Study Overview
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Brief Summary
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The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.

Official Title
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Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift

Conditions
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Edentulous

Intervention / Treatment
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* Procedure: Image-guided surgery
* Procedure: Sinus lift surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and more sinus lift enough remaining bone for image guided implant placement Exclusion Criteria: pregnancy chronic disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Image-guided surgery<br>Image-guided implant placement | Procedure: Image-guided surgery<br>* Placement on residual bone around the implant<br>|
| Sham Comparator: sinus graft<br>Sinus lift surgery : Patients receive sinus graft before implant placement | Procedure: Sinus lift surgery<br>* Allograft bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | Treatment success is defined as followed : a yes must be obtain for the 4 following item. Each implant are placed as planned (location and time) before surgery for each patient Implant stability for each implant at follow-up stage No radiolucent image around each implant No pain no infection and paresthesia around each implant | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the image guided system used | Implant placed or not | During surgery | 
| Treatment success |  | 5 years | 
| Replacement of missing teeth |  | 4 month after surgery | 
| Angulation of implant |  | 4 month after surgery | 
| Cost of treatment | Medical economic aspect | 4 month after surgery | 
| Patient pain | Pain is evaluated by the patient using both a analogic visual scale ranging from 0 to 10 and qualitative data (null, moderate, important, severe). Time of pain evaluation: Arm: graft procedure Day of graft procedure 1 week after graft procedure Day of implant placement (6 months after graft) 1 week after implant placement Arm: image-guided surgery Day of implant placement 1 week after implant placement | 1 week after implant placement procedure | 
| Patient satisfaction | Satisfaction is evaluated using qualitative data after surgery (how unconfortable was the surgery: very hard, hard, not hard, no opinion) and 1 year after prosthesis loading (treatment fulfill your expectation: no - not satisfied - satisfied - very satisfied. After surgery (graft procedure and implant placement, the following question is also asked to the patient : would you recommend the surgical procedure to a friend. Time of satisfaction evaluation: Arm : graft procedure 1 week after graft surgery 1 week after implant placement 1 year after prosthesis loading Arm : image-guided surgery 1 week after surgery (implant placement) 1 year after prosthesis loading | 1 year after prosthesis loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided surgery, Sinus graft