Guided Surgery Versus Sinus Graft (SINIMAGE)

September 8, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69365
        • Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and more
  • sinus lift
  • enough remaining bone for image guided implant placement

Exclusion Criteria:

  • pregnancy
  • chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the image guided system used
Time Frame: During surgery
Implant placed or not
During surgery
Treatment success
Time Frame: 5 years
5 years
Replacement of missing teeth
Time Frame: 4 month after surgery
4 month after surgery
Angulation of implant
Time Frame: 4 month after surgery
4 month after surgery
Cost of treatment
Time Frame: 4 month after surgery
Medical economic aspect
4 month after surgery
Patient pain
Time Frame: 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
1 week after implant placement procedure
Patient satisfaction
Time Frame: 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
1 year after prosthesis loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Thomas FORTIN, Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2009

Primary Completion (Actual)

November 12, 2019

Study Completion (Actual)

November 12, 2019

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimated)

November 20, 2013

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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