Status:
UNKNOWN
Evaluation of the Safety and Performance of Glycobone in Sinus Lift
Lead Sponsor:
SILTISS
Conditions:
Sinus Elevation
Bone Substitute
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
Multicentre, interventional, longitudinal, open-label study conducted in France, evaluating the clinical performance and safety of Glycobone® as a bone filling material in the context of a lateral app...
Detailed Description
A multicentre, interventional, longitudinal, open-label, prospective, pilot exploratory study of first-in-man administration in France, evaluating the clinical performance, safety and bone filling pro...
Eligibility Criteria
Inclusion
- 1\. Adult patient, male or female, aged 18-84 years at the time of signing the consent form
- 2\. Patient who has been informed and has signed consent prior to any procedure related to the investigation 3. Patient requiring a dental implant procedure:
- Implant project associated with at least one lateral approach sinus lift due to sub-sinus bone height \< 5 mm, without full bridge
- Associated with a bone filling
- With implant placement deferred to approximately 6 months within the limit of a maximum of 3 implants in the framework of the investigation 4. Availability of a cone beam with radiological guide less than 3 months old 5. Patient covered by a health insurance plan.
Exclusion
- 3 months or less old tooth extraction (≤ 3 months)
- Sinus lift project requiring placement of all contralateral implants at the same time (i.e. 2 sinus lift projects associated with a full bridge)
- Contralateral sinus lift of the site to be included performed within 3 months prior to inclusion
- 4\. Patient's general condition does not allow the investigator to perform the investigative procedures
- Pregnant or breastfeeding patient at the time of the sinus lift and filling procedure (D0)
- Patient with a concomitant ENT infection that may interfere with the investigative procedures
- Patient with an uncontrolled chronic condition that may interfere with investigative procedures
- Patient on VKA with INR \>4, biphosphonates, denosumab or having been treated with radiotherapy in the study area
- Patient unable to receive any type of analgesic during the investigation
- Patient allergic to any of the components of Glycobone®.
- Patient participating or having participated in another drug or medical device clinical trial within 30 days prior to inclusion in this study
- Patient considered by the investigator to be non-compliant with study procedures
- Patient deprived of liberty by court or administrative order or under legal protection (e.g. guardianship)
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 16 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05377710
Start Date
May 16 2022
End Date
May 16 2022
Last Update
May 17 2022
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