Guided Surgery Versus Sinus Graft

Edentulous Clinical Trial

— SINIMAGE  

Official title:

Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988480
• Other study ID #: 2008.514
• Status: Completed
• Phase: N/A
• Start date: July 8, 2009
• Est. completion date: November 12, 2019

Study information

• Verified date: June 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and more

• sinus lift

• enough remaining bone for image guided implant placement

Exclusion Criteria:

• pregnancy

• chronic disease

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Procedure:
• Image-guided surgery
Placement on residual bone around the implant
• Sinus lift surgery
Allograft bone

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires	Lyon cedex 07

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accuracy of the image guided system used	Implant placed or not	During surgery
Secondary	Treatment success		5 years
Secondary	Replacement of missing teeth		4 month after surgery
Secondary	Angulation of implant		4 month after surgery
Secondary	Cost of treatment	Medical economic aspect	4 month after surgery
Secondary	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	1 week after implant placement procedure
Secondary	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	1 year after prosthesis loading