Guided Surgery Versus Sinus Graft

Not Applicable

Completed

• Conditions: Edentulous
• Interventions: Procedure: Image-guided surgery; Procedure: Sinus lift surgery

• Registration Number: NCT01988480
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-08
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Image-guided surgery	Image-guided surgery	Image-guided implant placement
sinus graft	Sinus lift surgery	Sinus lift surgery : Patients receive sinus graft before implant placement

Primary Outcome Measures

Name	Time	Method
Treatment success	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

Secondary Outcome Measures

Name	Time	Method
Treatment success	5 years
Angulation of implant	4 month after surgery
Accuracy of the image guided system used	During surgery	Implant placed or not
Cost of treatment	4 month after surgery	Medical economic aspect
Patient satisfaction	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
Replacement of missing teeth	4 month after surgery
Patient pain	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

Trial Locations

Locations (1)

Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires; 🇫🇷 Lyon cedex 07, France