NCT05377710

Evaluation of the Safety and Performance of Glycobone in Sinus Lift

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: SILTISS · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Sinus Elevation
• Bone Substitute

Interventions

Type	Name	Description
PROCEDURE	sinus lift with lateral approach	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

Timeline

• Start date: 2022-05-16
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2022-05-17
• Last updated: 2022-05-17