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A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
November 1, 2025
Primary Completion Date
July 31, 2026
Completion Date
July 31, 2026
Last Updated
September 3, 2025
200
ESTIMATED participants
Dental Barrier Membrane
DEVICE
Lead Sponsor
Nobel Biocare
NCT05500755
NCT07019428
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06692244