Dental ImplantEvolutionNCT04736771
Study Assessing the Safety and Effectiveness of the Nobel Biocare N1 Concept System.
An observational study of Dental Implant, run by Nobel Biocare at 3 sites in 3 countries.
Trial summary
Standard medical and dental forms from all subjects (i.e., adults ≥18 years old in need of a dental implant) who have been treated for CS Tiger Ultra Implant TCC RP dental implant treatment at the participating Clinics will be reviewed and clinical data will be obtained, only upon the receipt of Ethical Committee's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant
- How many people
- 95 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 May 2021to 16 Sep 2021
- 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
- Adult, Older adult
Study population: All subjects (i.e., adults ≥18 years old in need of a dental implant) who have been treated for CS Tiger Ultra Implant TCC RP dental implant treatment at the participating Clinics in the period from April 2019 until December 2019 at the corresponding participant Clinics
Who may be able to join
- Subject is ≥18 years of age
- Signed of Informed Consent Form*
- Signed Personal Data Processing (GDPR) Form**
- Subject received Nobel Biocare N1 Concept System implants.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Retrospective Real-world Evidence Study Assessing the Safety and Effectiveness of the Nobel Biocare N1 Concept System.
Standard medical and dental forms from all subjects (i.e., adults ≥18 years old in need of a dental implant) who have been treated for CS Tiger Ultra Implant TCC RP dental implant treatment at the participating Clinics will be reviewed and clinical data will be obtained, only upon the receipt of Ethical Committee's approval and upon subject's signature of the corresponding Informed Consent Form.
All raw study data will be de-identified and corresponding subject information recorded in the data accrual system (e-CRF Smart Trial). Information recorded by the researcher shall not identify the subject and no individually identifiable data elements shall be recorded. The researcher shall receive a link to log in to e CRF system. The researcher will be asked to create an account and every log-in attempt into the system shall be controlled by an unique code. Radiographic measurements of marginal bone level mesial and distal to the implant (at time of surgery, implant loading and 12-months follow-up post-loading) carried out according to the standard practice of the clinic will be collected for the assessment of the marginal bone levels changes. Data will be anonymized before the x-ray collection.
An independent radiologist shall be responsible for the evaluation of the radiographic data. The Sponsor shall send to the radiologist all corresponding radiographic files entitled by study code, clinic and patient number, implant position and implant characteristics (diameter and/or length - where available) together with an Excel sheet where the Radiologist can accurately track the corresponding bone level measurements.
Read the detailed description
This study is a retrospective observational multi-center study. It will include data from 70 up to 100 subjects, treated with the N1 Concept System. The study will be conducted in up to six European centers (Appendix I - Participating Institutions).
The study will collect clinical and radiographic data related to the surgery and up to 12-months after loading (a time window of ± 3-months is accepted).
Study subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.
All participating subjects must have signed the Informed Consent Form together with a separate Consent Form regarding personal data processing (if not waived by the corresponding Ethical Committee). Retrospective data collection will only start after signatures have been provided.
The investigator will check subjects' medical and dental chart and assign a study ID number to each subject. The corresponding study required information will be de-identified and entered into the electronic study database.
All x-ray images, from the area of treatment, that were made up until 12-months after implant loading will be de-identified before uploaded to the study database or otherwise sent to the sponsor.
No personal/confidential information (e.g.: full name or initials, date of birth, social security number, etc.) that could reveal subject's identity will be recorded in the study database.
Endpoints
Primary endpoint The primary endpoint is to evaluate the marginal bone level change of the N1 Concept System from loading to 12-months post loading. Patients with matched readable radiographs are included.
Secondary endpoints
- Implant survival and success rates at 12-months after loading.
- Soft tissue healing parameters (i.e. bleeding index, plaque index, etc.) at 12-months after loading.
- Safety recorded by AE, SAE, ADE, SADE, USADE, and DD.
- Conditions
- Dental Implant
- Keywords
- implant site preparation tools, implant system
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level and marginal bone levels changes
Measured: 12-months post loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start18 May 2021
- Primary completion10 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736771
- Sponsor's protocol ID
- T-193
- Acronym
- Evolution
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fabbri G, Staas T, Urban I. A Retrospective Observational Study Assessing the Clinical Outcomes of a Novel Implant System with Low-Speed Site Preparation Protocol and Tri-Oval Implant Geometry. J Clin Med. 2022 Aug 18;11(16):4859. doi: 10.3390/jcm11164859.
PubMed 36013098
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Real-world Evidence Study Assessing the Safety and Effectiveness of the Nobel Biocare N1 Concept System.
- ClinicalTrials.gov ID
- NCT04736771
- Acronym / sponsor ID
- Evolution / T-193
- Conditions
- Dental Implant
- Keywords
- implant site preparation tools, implant system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 3 Feb 2021 (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.
Standard medical and dental forms from all subjects (i.e., adults ≥18 years old in need of a dental implant) who have been treated for CS Tiger Ultra Implant TCC RP dental implant treatment at the participating Clinics will be reviewed and clinical data will be obtained, only upon the receipt of Ethical Committee's approval and upon subject's signature of the corresponding Informed Consent Form.
All raw study data will be de-identified and corresponding subject information recorded in the data accrual system (e-CRF Smart Trial). Information recorded by the researcher shall not identify the subject and no individually identifiable data elements shall be recorded. The researcher shall receive a link to log in to e CRF system. The researcher will be asked to create an account and every log-in attempt into the system shall be controlled by an unique code. Radiographic measurements of marginal bone level mesial and distal to the implant (at time of surgery, implant loading and 12-months follow-up post-loading) carried out according to the standard practice of the clinic will be collected for the assessment of the marginal bone levels changes. Data will be anonymized before the x-ray collection.
An independent radiologist shall be responsible for the evaluation of the radiographic data. The Sponsor shall send to the radiologist all corresponding radiographic files entitled by study code, clinic and patient number, implant position and implant characteristics (diameter and/or length - where available) together with an Excel sheet where the Radiologist can accurately track the corresponding bone level measurements.
Detailed description
This study is a retrospective observational multi-center study. It will include data from 70 up to 100 subjects, treated with the N1 Concept System. The study will be conducted in up to six European centers (Appendix I - Participating Institutions).
The study will collect clinical and radiographic data related to the surgery and up to 12-months after loading (a time window of ± 3-months is accepted).
Study subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.
All participating subjects must have signed the Informed Consent Form together with a separate Consent Form regarding personal data processing (if not waived by the corresponding Ethical Committee). Retrospective data collection will only start after signatures have been provided.
The investigator will check subjects' medical and dental chart and assign a study ID number to each subject. The corresponding study required information will be de-identified and entered into the electronic study database.
All x-ray images, from the area of treatment, that were made up until 12-months after implant loading will be de-identified before uploaded to the study database or otherwise sent to the sponsor.
No personal/confidential information (e.g.: full name or initials, date of birth, social security number, etc.) that could reveal subject's identity will be recorded in the study database.
Endpoints
Primary endpoint The primary endpoint is to evaluate the marginal bone level change of the N1 Concept System from loading to 12-months post loading. Patients with matched readable radiographs are included.
Secondary endpoints
- Implant survival and success rates at 12-months after loading.
- Soft tissue healing parameters (i.e. bleeding index, plaque index, etc.) at 12-months after loading.
- Safety recorded by AE, SAE, ADE, SADE, USADE, and DD.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All subjects (i.e., adults ≥18 years old in need of a dental implant) who have been treated for CS Tiger Ultra Implant TCC RP dental implant treatment at the participating Clinics in the period from April 2019 until December 2019 at the corresponding participant Clinics
Key inclusion criteria (4 listed)
- Subject is ≥18 years of age
- Signed of Informed Consent Form*
- Signed Personal Data Processing (GDPR) Form**
- Subject received Nobel Biocare N1 Concept System implants.
Key exclusion criteria (0 listed)
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
Marginal Bone Level and marginal bone levels changes
Time frame: 12-months post loading
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 11 Oct 2021.
- Derived from this study: PubMed 36013098Fabbri G, Staas T, Urban I. A Retrospective Observational Study Assessing the Clinical Outcomes of a Novel Implant System with Low-Speed Site Preparation Protocol and Tri-Oval Implant Geometry. J Clin Med. 2022 Aug 18;11(16):4859. doi: 10.3390/jcm11164859.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant, run by Nobel Biocare at 3 sites in 3 countries.
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 4 inclusion and 0 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary, Italy, Netherlands. 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?
Marginal Bone Level and marginal bone levels changes (time frame: 12-months post loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736771, which also lists 1 linked publication.
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 11 Oct 2021.