Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycobone | Experimental | Patients will be implanted at T0 with Glycobone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sinus lift with lateral approach | Procedure | Maxillary sinus floor augmentation or sinus lift is a surgical procedure, which provides a solution to the problem of sinus bone loss (too thin), and thus increases the thickness of the bone for immediate or subsequent implant placement in the premolars and molars (4). It consists of the elevation of the sinus mucosa that lines the maxillary sinus. The space thus freed will be filled with a bone filling material |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the success rate of the implantation at 6 months | The primary endpoint of the investigation is the success rate at M6 defined as the number of successfully placed implants (with sufficient bone formation judged by the implantologist and an implant judged to be stable) compared to the total number of implants planned to be placed at the beginning of the treatment | 6 months after implantation |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine AUGET | Contact | +33 (0)5 55 84 58 40 | s.auget@siltiss.fr | |
| Didier LETOURNEUR | Contact | +33 (0)5 55 84 58 40 | didier.letourneur@siltiss.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean PAUFIQUE | SILTISS | Study Director |
| Sylvain CATROS | University Hospital, Bordeaux | Principal Investigator |
Not provided
It is a private study belonging to SILTISS; the data will not be transmitted to other scientists but will remain within SILTISS to be valorised
Not provided
Not provided
Not provided
Not provided
Not provided
human
Not provided
Not provided
Not provided
Not provided
|
|