Evaluation of the Safety and Performance of Glycobone in Sinus Lift — SL  

Bone Substitute Clinical Trial

Official title: Multicentre, Interventional, Longitudinal, Open-label Study Conducted in France Evaluating the Clinical Performance and Safety of Glycobone® as a Bone Filler in a Lateral Sinus Lift Setting

Status Not yet recruiting

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bone Substitute

• NCT number: NCT05377710
• Study type: Interventional
• Source: SILTISS
• Contact: Sandrine AUGET
• Phone: +33 (0)5 55 84 58 40
• Email: s.auget@siltiss.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 16, 2022
• Completion date: May 16, 2022