Creos Xenoprotect PMCF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental Barrier Membrane.
- Who it may be relevant to
- Registry conditions: Bone Regeneration, Dental Implants, Bone Grafting. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)
Overview
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
Interventions
- Device Dental Barrier Membrane
Patients treated with creos xenoprotect dental barrier membrane in the past
Primary outcome measures
- Occurrence of major complications during 6 months after creos xenoprotect placement [Time frame: From Surgery to 6 Months Follow-Up]
Secondary outcome measures (4)
- Occurence of minor complications (dehiscence, membrane exposure, infection) during 6 months after placement of creos xenoprotect [Time frame: From Surgery to 6 Months Follow-Up]
- Number of cases with successful bone graft: o Implants: sufficient bone at implant insertion visit o No implants: additional bone grafting intervention needed at 6 Months Follow-Up [Time frame: From Surgery to 6 Months Follow-Up]
- Clinician satisfaction / handling with creos xenoprotect at Membrane Placement (VAS Scale) [Time frame: At Surgery]
- SAE, SADE, USADE, DD [Time frame: From Surgery to 9 Months Follow-Up]
Eligibility criteria
Inclusion criteria
- Participant was treated before December 2023 (creos xenoprotect placement)
- Participant signed informed consent form and data protection consent form1
- Participant was at least 18 years old at the time of treatment
- Participant received guided bone regeneration combined with the use of creos xenoprotect according to one of the four indications
- Participant was treated according to instructions for use (IFU)
- Participant should have follow-up time of >9 months after placement of the investigational device
Exclusion criteria
- In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07153185 · T-195