EdentulousSINIMAGENCT01988480
Guided Surgery Versus Sinus Graft
A study testing Image-guided surgery and Sinus lift surgery in people with Edentulous, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous
- What is being tested?
- Image-guided surgery and Sinus lift surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2009to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and more
- sinus lift
- enough remaining bone for image guided implant placement
Who cannot join
- pregnancy
- chronic disease
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
Lyon, 69365
About this study
Official title: Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.
- Conditions
- Edentulous
- Being tested
- Image-guided surgery, Sinus lift surgery
- Keywords
- Guided surgery, Sinus graft
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided surgeryProcedure or surgery
Placement on residual bone around the implant
Sinus lift surgeryProcedure or surgery
Allograft bone
| Study group | Role | What they receive |
|---|---|---|
| Image-guided surgery | Experimental | Image-guided implant placement Receives: Procedure: Image-guided surgery |
| sinus graft | Sham comparator | Sinus lift surgery : Patients receive sinus graft before implant placement Receives: Procedure: Sinus lift surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (7)
Accuracy of the image guided system used
Implant placed or not
Measured: During surgery
Treatment success
Measured: 5 years
Replacement of missing teeth
Measured: 4 month after surgery
Angulation of implant
Measured: 4 month after surgery
Cost of treatment
Medical economic aspect
Measured: 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
Measured: 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
Measured: 1 year after prosthesis loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start8 Jul 2009
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdentulousStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas FORTIN, Principal investigator, Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988480
- Sponsor's protocol ID
- 2008.514
- Acronym
- SINIMAGE
- Status last verified
- Jun 2020
- First submitted
- 18 Sep 2013
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32344891
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift
- ClinicalTrials.gov ID
- NCT01988480
- Acronym / sponsor ID
- SINIMAGE / 2008.514
- Conditions
- Edentulous
- Keywords
- Guided surgery, Sinus graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Jul 2009 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Image-guided surgery | Experimental | Procedure: Image-guided surgeryImage-guided implant placement |
| sinus graft | Sham comparator | Procedure: Sinus lift surgerySinus lift surgery : Patients receive sinus graft before implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and more
- sinus lift
- enough remaining bone for image guided implant placement
Key exclusion criteria (2 listed)
- pregnancy
- chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-guided surgeryPlacement on residual bone around the implant | Procedure or surgery | Image-guided surgery |
| Sinus lift surgeryAllograft bone | Procedure or surgery | sinus graft |
Primary outcome
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
7 secondary outcomes
Accuracy of the image guided system used
Time frame: During surgery
Treatment success
Time frame: 5 years
Replacement of missing teeth
Time frame: 4 month after surgery
Angulation of implant
Time frame: 4 month after surgery
Cost of treatment
Time frame: 4 month after surgery
Patient pain
Time frame: 1 week after implant placement procedure
Patient satisfaction
Time frame: 1 year after prosthesis loading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 32344891Almahrous 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas FORTIN principal investigator
Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-guided surgery and Sinus lift surgery in people with Edentulous, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.