Bone RegenerationNCT07153185
Creos Xenoprotect PMCF
An observational study of Bone Regeneration and Dental Implants, run by Nobel Biocare.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Regeneration, Dental Implants, Bone Grafting
- What is being tested?
- Dental Barrier Membrane
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane
About this study
Official title: A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)
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.
Read more
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
- Being tested
- Dental Barrier Membrane
- Keywords
- Dental Barrier Membrane, PMCF Study, Retrospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Barrier MembraneDevice
Patients treated with creos xenoprotect dental barrier membrane in the past
| Study group | Role | What they receive |
|---|---|---|
| main study population | Not described Receives: Device: Dental Barrier Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major complications during 6 months after creos xenoprotect placement
Measured: 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
Measured: 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
Measured: 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
Measured: At Surgery
SAE, SADE, USADE, DD
Measured: From Surgery to 9 Months Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153185
- Sponsor's protocol ID
- T-195
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)
- ClinicalTrials.gov ID
- NCT07153185
- Acronym / sponsor ID
- T-195
- Conditions
- Bone Regeneration, Dental Implants, Bone Grafting
- Keywords
- Dental Barrier Membrane, PMCF Study, Retrospective
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main study population | – | Device: Dental Barrier Membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Participant was treated before December 2023 (creos xenoprotect placement)
Key exclusion criteria (1 listed)
- In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Barrier MembranePatients treated with creos xenoprotect dental barrier membrane in the past | Device | main study population |
Primary outcome
Occurrence of major complications during 6 months after creos xenoprotect placement
Time frame: From Surgery to 6 Months Follow-Up
4 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)
Time frame: At Surgery
SAE, SADE, USADE, DD
Time frame: From Surgery to 9 Months Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Regeneration and Dental Implants, run by Nobel Biocare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major complications during 6 months after creos xenoprotect placement (time frame: From Surgery to 6 Months Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.