Evaluation of the Safety and Performance of Glycobone in Sinus Lift (SL)

SILTISS

Status: Unknown

Conditions: Bone Substitute; Sinus Elevation

Treatments: Procedure: sinus lift with lateral approach

Study type: Interventional

Funder types: Industry

Identifiers

NCT05377710

2020-A02457-32

Details and patient eligibility

About

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 approach sinus lift on 40 patients with dental implant placement. Implant placement took place 6 months after bone filling.

Full 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 properties of Glycobone® during a lateral sinus lift procedure with deferred implant placement.

The study will follow a panel of 40 patients for 9 months in three consecutive stages:

Stage 1: Inclusion of a group of up to 5 patients Stage 2: If safety validation in stage 1 is confirmed: Inclusion of a group of 15 additional patients (maximum) Step 3: If safety validation in step 2 is confirmed: Inclusion of a group of 20 additional patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

1. 3 months or less old tooth extraction (≤ 3 months)
2. Sinus lift project requiring placement of all contralateral implants at the same time (i.e. 2 sinus lift projects associated with a full bridge)
3. Contralateral sinus lift of the site to be included performed within 3 months prior to inclusion
4. 4. Patient's general condition does not allow the investigator to perform the investigative procedures
5. Pregnant or breastfeeding patient at the time of the sinus lift and filling procedure (D0)
6. Patient with a concomitant ENT infection that may interfere with the investigative procedures
7. Patient with an uncontrolled chronic condition that may interfere with investigative procedures
8. Patient on VKA with INR >4, biphosphonates, denosumab or having been treated with radiotherapy in the study area
9. Patient unable to receive any type of analgesic during the investigation
10. Patient allergic to any of the components of Glycobone®.
11. Patient participating or having participated in another drug or medical device clinical trial within 30 days prior to inclusion in this study
12. Patient considered by the investigator to be non-compliant with study procedures
13. Patient deprived of liberty by court or administrative order or under legal protection (e.g. guardianship)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Glycobone

Experimental group

Description:

Patients will be implanted at T0 with Glycobone

Treatment:

Procedure: sinus lift with lateral approach