NCT07153185

Creos Xenoprotect PMCF

A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Nobel Biocare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this retrospective PMCF study is to assess safety and performance of creos xenoprotect in all indications functioning as dental barrier membrane. The primary endpoint of the study is the occurrence of major complications during 6 months after creos xenoprotect placement whereas the hypothesis is that these major complications occur in less than 5% within this timeframe. This is a retrospective, multicenter clinical investigation with consecutive cases. Data will be collected on consecutive data cases from patient files, given that these patients were treated within a defined indication with creos xenoprotect in the past. Patients participating in this study do not have any obligations or need to come back for any intervention. A total of 11 centers are planned to be included. Sample size is n=200 patients and is distributed equally in four indication groups: Group 1: Ridge augmentation (vertical and horizontal) Group 2: Alveolar ridge preservation Group 3: Sinus floor augmentation Group 4: Augmentation around implant or teeth

Conditions

• Bone Regeneration
• Dental Implants
• Bone Grafting

Interventions

Type	Name	Description
DEVICE	Dental Barrier Membrane	Patients treated with creos xenoprotect dental barrier membrane in the past

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-09-03
• Last updated: 2025-09-03

Regulatory

• FDA-regulated device study