Guided Surgery Versus Sinus Graft

Overview

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

Full Title of Study: “Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 12, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Image-guided surgery
    • Image-guided implant placement
  • Sham Comparator: sinus graft
    • Sinus lift surgery : Patients receive sinus graft before implant placement

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Accuracy of the image guided system used
    • Time Frame: During surgery
    • Implant placed or not
  • 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
    • Medical economic aspect
  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years and more – sinus lift – enough remaining bone for image guided implant placement Exclusion Criteria:

  • pregnancy – chronic disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas FORTIN, Principal Investigator, Hospices Civils de Lyon – Service de Consultations et Traitements Dentaires

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