Creos Xenoprotect PMCF

N/ANot Yet RecruitingNCT07153185

Nobel Biocare200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Bone Regeneration Dental Implants Bone Grafting

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurrence of major complications during 6 months after creos xenoprotect placement

Time frame: From Surgery to 6 Months Follow-Up

Secondary Outcomes

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

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

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

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

Time frame: At Surgery

SAE, SADE, USADE, DD

Time frame: From Surgery to 9 Months Follow-Up