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Guided Surgery Versus Sinus Graft (SINIMAGE)

Primary Purpose

Edentulous

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Image-guided surgery
Sinus lift surgery
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous focused on measuring Guided surgery, Sinus graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • chronic disease

Sites / Locations

  • Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Image-guided surgery

sinus graft

Arm Description

Image-guided implant placement

Sinus lift surgery : Patients receive sinus graft before implant placement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Accuracy of the image guided system used
Implant placed or not
Treatment success
Replacement of missing teeth
Angulation of implant
Cost of treatment
Medical economic aspect
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
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

Full Information

First Posted
September 18, 2013
Last Updated
June 11, 2020
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01988480
Brief Title
Guided Surgery Versus Sinus Graft
Acronym
SINIMAGE
Official Title
Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 8, 2009 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous
Keywords
Guided surgery, Sinus graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Image-guided surgery
Arm Type
Experimental
Arm Description
Image-guided implant placement
Arm Title
sinus graft
Arm Type
Sham Comparator
Arm Description
Sinus lift surgery : Patients receive sinus graft before implant placement
Intervention Type
Procedure
Intervention Name(s)
Image-guided surgery
Intervention Description
Placement on residual bone around the implant
Intervention Type
Procedure
Intervention Name(s)
Sinus lift surgery
Intervention Description
Allograft bone
Primary Outcome Measure Information:
Title
Treatment success
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Accuracy of the image guided system used
Description
Implant placed or not
Time Frame
During surgery
Title
Treatment success
Time Frame
5 years
Title
Replacement of missing teeth
Time Frame
4 month after surgery
Title
Angulation of implant
Time Frame
4 month after surgery
Title
Cost of treatment
Description
Medical economic aspect
Time Frame
4 month after surgery
Title
Patient pain
Description
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
Time Frame
1 week after implant placement procedure
Title
Patient satisfaction
Description
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
Time Frame
1 year after prosthesis loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and more sinus lift enough remaining bone for image guided implant placement Exclusion Criteria: pregnancy chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas FORTIN
Organizational Affiliation
Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires
City
Lyon cedex 07
ZIP/Postal Code
69365
Country
France

12. IPD Sharing Statement

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Guided Surgery Versus Sinus Graft

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