Creos Xenoprotect PMCF
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNobel Biocare
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane
Trial population
Adult participants (aged ≥ 18y) that underwent guided bone regeneration combined with the use of creos xenoprotect according to one of the four indications are included in the study.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Dental Barrier Membrane
DevicePatients treated with creos xenoprotect dental barrier membrane in the past
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: main study population1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of major complications during 6 months after creos xenoprotect placement
Time frame
From Surgery to 6 Months Follow-UpSecondary outcomes
1
Occurence of minor complications (dehiscence, membrane exposure, infection) during 6 months after placement of creos xenoprotect
Time frame
From Surgery to 6 Months Follow-Up2
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-Up3
Clinician satisfaction / handling with creos xenoprotect at Membrane Placement (VAS Scale)
Visual Analog Scale, Score 1-10, 1: not satisfied at all; 10: totally satisfied
Time frame
At Surgery4
SAE, SADE, USADE, DD
Time frame
From Surgery to 9 Months Follow-UpOther outcomes
1
Implant survival (at final prosthesis delivery and last follow-up)
Time frame
From Surgery to 9 Months Follow-Up2
Bone gain (between membrane placement and follow-up visits)
Time frame
From Surgery to 9 Months Follow-Up3
Bleeding Index
Time frame
From Final Prosthesis Placement to 9 Months Follow-Up4
Plaque Index
Time frame
From Final Prosthesis Placement to 9 Months Follow-UpLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: