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NCT Number: NCT07153185

Creos Xenoprotect PMCF

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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Key information

Conditions

Bone Regeneration Bone Grafting Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental Barrier Membrane

Device

Patients treated with creos xenoprotect dental barrier membrane in the past

Primary outcomes

  1. Occurrence of major complications during 6 months after creos xenoprotect placement

    Time frame: From Surgery to 6 Months Follow-Up

Secondary 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-Up

  2. 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-Up

  3. Clinician satisfaction / handling with creos xenoprotect at Membrane Placement (VAS Scale)

    Time frame: At Surgery

    Visual Analog Scale, Score 1-10, 1: not satisfied at all; 10: totally satisfied

  4. SAE, SADE, USADE, DD

    Time frame: From Surgery to 9 Months Follow-Up

Other outcomes

  1. Implant survival (at final prosthesis delivery and last follow-up)

    Time frame: From Surgery to 9 Months Follow-Up

  2. Bone gain (between membrane placement and follow-up visits)

    Time frame: From Surgery to 9 Months Follow-Up

  3. Bleeding Index

    Time frame: From Final Prosthesis Placement to 9 Months Follow-Up

  4. Plaque Index

    Time frame: From Final Prosthesis Placement to 9 Months Follow-Up

  5. Gingival Index

    Time frame: From Final Prosthesis Placement to 9 Months Follow-Up

  6. Keratinized Mucosa Height

    Time frame: From Final Prosthesis Placement to 9 Months Follow-Up

    [mm]

  7. Gingival Thickness

    Time frame: From Final Prosthesis Placement to 9 Months Follow-Up

    [mm]

  8. Buccal Soft Tissue Thickness

    Time frame: From Final Prosthesis Placement to 9 Months Follow-Up

    [mm]

Sponsors and collaborators

Lead sponsor

Nobel Biocare

Industry

Registry information

Official study title

A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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