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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| main study population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Barrier Membrane | Device | Patients treated with creos xenoprotect dental barrier membrane in the past |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major complications during 6 months after creos xenoprotect placement | From Surgery to 6 Months Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of minor complications (dehiscence, membrane exposure, infection) during 6 months after placement of creos xenoprotect | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival (at final prosthesis delivery and last follow-up) | From Surgery to 9 Months Follow-Up | |
| Bone gain (between membrane placement and follow-up visits) | From Surgery to 9 Months Follow-Up | |
Inclusion Criteria:
Participant was treated before December 2023 (creos xenoprotect placement)
Exclusion Criteria:
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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.
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| From Surgery to 6 Months Follow-Up |
| 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 | At Surgery |
| SAE, SADE, USADE, DD | From Surgery to 9 Months Follow-Up |
| Bleeding Index |
| From Final Prosthesis Placement to 9 Months Follow-Up |
| Plaque Index | From Final Prosthesis Placement to 9 Months Follow-Up |
| Gingival Index | From Final Prosthesis Placement to 9 Months Follow-Up |
| Keratinized Mucosa Height | [mm] | From Final Prosthesis Placement to 9 Months Follow-Up |
| Gingival Thickness | [mm] | From Final Prosthesis Placement to 9 Months Follow-Up |
| Buccal Soft Tissue Thickness | [mm] | From Final Prosthesis Placement to 9 Months Follow-Up |