Creos Xenoprotect PMCF

Not yet recruiting

• Conditions: Bone Regeneration; Dental Implants; Bone Grafting

• Registration Number: NCT07153185
• Lead Sponsor: Nobel Biocare

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-11-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of major complications during 6 months after creos xenoprotect placement	From Surgery to 6 Months Follow-Up

Secondary Outcome Measures

Name	Time	Method
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