NCT01988480CompletedNot Applicable
Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Treatment success
Study Overview
Brief Summary
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years and more
- •sinus lift
- •enough remaining bone for image guided implant placement
Exclusion Criteria
- •pregnancy
- •chronic disease
Arms & Interventions
Image-guided surgery
Experimental
Image-guided implant placement
Intervention: Image-guided surgery (Procedure)
sinus graft
Sham Comparator
Sinus lift surgery : Patients receive sinus graft before implant placement
Intervention: Sinus lift surgery (Procedure)
Outcomes
Primary Outcomes
Treatment success
Time Frame: 2 years
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
Secondary Outcomes
- Treatment success(5 years)
- Angulation of implant(4 month after surgery)
- Accuracy of the image guided system used(During surgery)
- Cost of treatment(4 month after surgery)
- Patient satisfaction(1 year after prosthesis loading)
- Replacement of missing teeth(4 month after surgery)
- Patient pain(1 week after implant placement procedure)
Investigators
Study Sites (1)
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