Edentulous
Conditions
Keywords
Guided surgery, Sinus graft
Brief summary
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.
Interventions
PROCEDUREImage-guided surgery
Placement on residual bone around the implant
PROCEDURESinus lift surgery
Allograft bone
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and more * sinus lift * enough remaining bone for image guided implant placement
Exclusion criteria
* pregnancy * chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 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
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the image guided system used | During surgery | Implant placed or not |
| Treatment success | 5 years | — |
| Replacement of missing teeth | 4 month after surgery | — |
| Angulation of implant | 4 month after surgery | — |
| Cost of treatment | 4 month after surgery | Medical economic aspect |
| Patient pain | 1 week after implant placement procedure | 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 |
| Patient satisfaction | 1 year after prosthesis loading | 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 |
Countries
France
Outcome results
None listed