Creos Xenoprotect PMCF

Nobel Biocare

Status: Not yet enrolling

Conditions: Bone Grafting; Dental Implants; Bone Regeneration

Treatments: Device: Dental Barrier Membrane

Study type: Observational

Funder types: Industry

Identifiers

NCT07153185

T-195

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

main study population

Treatment:

Device: Dental Barrier Membrane