Bone Grafting, Bone Regeneration, Dental Implants
Conditions
Keywords
Dental Barrier Membrane, PMCF Study, Retrospective
Brief 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
Interventions
DEVICEDental Barrier Membrane
Patients treated with creos xenoprotect dental barrier membrane in the past
Sponsors
Nobel Biocare
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of major complications during 6 months after creos xenoprotect placement | From Surgery to 6 Months Follow-Up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From Surgery to 6 Months Follow-Up | — |
| Clinician satisfaction / handling with creos xenoprotect at Membrane Placement (VAS Scale) | At Surgery | Visual Analog Scale, Score 1-10, 1: not satisfied at all; 10: totally satisfied |
| SAE, SADE, USADE, DD | From Surgery to 9 Months Follow-Up | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Keratinized Mucosa Height | From Final Prosthesis Placement to 9 Months Follow-Up | \[mm\] |
| Implant survival (at final prosthesis delivery and last follow-up) | From Surgery to 9 Months Follow-Up | — |
| Buccal Soft Tissue Thickness | From Final Prosthesis Placement to 9 Months Follow-Up | \[mm\] |
| Gingival Thickness | From Final Prosthesis Placement to 9 Months Follow-Up | \[mm\] |
| Bone gain (between membrane placement and follow-up visits) | 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 | — |
Outcome results
None listed