Guided Surgery Versus Sinus Graft
SINIMAGE
Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift
1 other identifier
interventional
60
1 country
1
Brief Summary
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2009
CompletedFirst Submitted
Initial submission to the registry
September 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2019
CompletedSeptember 9, 2025
June 1, 2020
10.4 years
September 18, 2013
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Accuracy of the image guided system used
During surgery
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
- +2 more secondary outcomes
Study Arms (2)
Image-guided surgery
EXPERIMENTALImage-guided implant placement
sinus graft
SHAM COMPARATORSinus lift surgery : Patients receive sinus graft before implant placement
Interventions
Eligibility Criteria
You may qualify if:
- years and more
- sinus lift
- enough remaining bone for image guided implant placement
You may not qualify if:
- pregnancy
- chronic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
Lyon, 69365, France
Related Publications (1)
Almahrous G, David-Tchouda S, Sissoko A, Rancon N, Bosson JL, Fortin T. Patient-Reported Outcome Measures (PROMs) for Two Implant Placement Techniques in Sinus Region (Bone Graft versus Computer-Aided Implant Surgery): A Randomized Prospective Trial. Int J Environ Res Public Health. 2020 Apr 25;17(9):2990. doi: 10.3390/ijerph17092990.
PMID: 32344891RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas FORTIN
Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2013
First Posted
November 20, 2013
Study Start
July 8, 2009
Primary Completion
November 12, 2019
Study Completion
November 12, 2019
Last Updated
September 9, 2025
Record last verified: 2020-06