Bone DefectsNCT07084506
RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA - 2023.02
An observational study of Bone Defects and Dental Area, run by Bioceramed at 1 site in Belgium.
Trial summary
This study, based on observations of clinical practice, aims to collect clinical data to update information on the performance and safety of the n-IBS® when used according to its intended purpose and current clinical applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Defects, Dental Area
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Dec 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population consists of adult patients (aged > 18 years old) undergoing reconstructive dental surgeries.
Who may be able to join
- Adult males or females (aged > 18 years old);
- Patients who were implanted with the synthetic bone substitute n-IBS® for the treatment of intrabony defects associated with periodontal disease or for bone augmentation procedures in the alveolar process and maxillary sinus regions.
Who cannot join
- Patients with infection at the implantation site;
- Patients with metabolic disorders affecting bone healing;
- Patients with immune system disorders;
- Patients with systemic conditions that impair bone healing.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center Cabinet Dentaire de Stomatologie & Implantologie
Brussels
About this study
Official title: RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA
This study, based on observations of clinical practice, aims to collect clinical data to update information on the performance and safety of the n-IBS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence to support the assessment of the device's safety and performance, contributing to the overall clinical evaluation of the product.
- Conditions
- Bone Defects, Dental Area
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint
Assessment of bone consolidation at the surgical site, based on the quantification of bone gain (mm) as measured through routine X-ray imaging, to evaluate osseous regeneration.
Measured: follow-up visits, through study completion, an average of 1 year
2. Safety Endpoint
Assessment of Adverse Events (AEs) related to n-IBS® during the follow-up period of patients.
Measured: Follow-up visits, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start31 Dec 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioceramed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084506
- Sponsor's protocol ID
- 2023.02
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA
- ClinicalTrials.gov ID
- NCT07084506
- Acronym / sponsor ID
- 2023.02
- Conditions
- Bone Defects, Dental Area
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BioceramedIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Jul 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.
This study, based on observations of clinical practice, aims to collect clinical data to update information on the performance and safety of the n-IBS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence to support the assessment of the device's safety and performance, contributing to the overall clinical evaluation of the product.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged > 18 years old) undergoing reconstructive dental surgeries.
Key inclusion criteria (2 listed)
- Adult males or females (aged > 18 years old);
- Patients who were implanted with the synthetic bone substitute n-IBS® for the treatment of intrabony defects associated with periodontal disease or for bone augmentation procedures in the alveolar process and maxillary sinus regions.
Key exclusion criteria (4 listed)
- Patients with infection at the implantation site;
- Patients with metabolic disorders affecting bone healing;
- Patients with immune system disorders;
- Patients with systemic conditions that impair bone healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance Endpoint
Time frame: follow-up visits, through study completion, an average of 1 year
Assessment of bone consolidation at the surgical site, based on the quantification of bone gain (mm) as measured through routine X-ray imaging, to evaluate osseous regeneration.
2. Safety Endpoint
Time frame: Follow-up visits, through study completion, an average of 1 year
Assessment of Adverse Events (AEs) related to n-IBS® during the follow-up period of patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Defects and Dental Area, run by Bioceramed at 1 site in Belgium.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance Endpoint (time frame: follow-up visits, through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 24 Jul 2025.