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OpenTrials
Completed

NCT Number: NCT01988480

Guided Surgery Versus Sinus Graft

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

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Key information

Conditions

Edentulous Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires

Lyon, 69365, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • chronic disease

Treatment and study plan

Image-guided surgery

Procedure

Placement on residual bone around the implant

Sinus lift surgery

Procedure

Allograft bone

Primary outcomes

  1. 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 outcomes

  1. Accuracy of the image guided system used

    Time frame: During surgery

    Implant placed or not

  2. Treatment success

    Time frame: 5 years

  3. Replacement of missing teeth

    Time frame: 4 month after surgery

  4. Angulation of implant

    Time frame: 4 month after surgery

  5. Cost of treatment

    Time frame: 4 month after surgery

    Medical economic aspect

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SINIMAGE

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2013
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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