Creos Xenoprotect PMCF

NCT07153185 | Not Yet Recruiting FDA Device

• 1 other identifier: T-195
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bone Regeneration; Dental Implants; Bone Grafting

Keywords

Dental Barrier Membrane; PMCF Study; Retrospective

Outcome Measures

Primary Outcomes (1)

• Occurrence of major complications during 6 months after creos xenoprotect placement

  From Surgery to 6 Months Follow-Up

Secondary Outcomes (4)

• 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

• SAE, SADE, USADE, DD

  From Surgery to 9 Months Follow-Up

Other Outcomes (8)

• 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

• Bleeding Index

  From Final Prosthesis Placement to 9 Months Follow-Up

Study Arms (1)

main study population

Device: Dental Barrier Membrane

Interventions

Dental Barrier Membrane DEVICE

Patients treated with creos xenoprotect dental barrier membrane in the past

main study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane

Sponsors & Collaborators

• Nobel Biocare: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08