ImplantT-190NCT03100448
A 1-year Clinical Investigation on the On1 Concept
A study testing On1 Concept in people with Implant, run by Nobel Biocare at 6 sites in 4 countries.
Trial summary
A 1-year Clinical Investigation on the On1 Concept. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant
- What is being tested?
- On1 Concept
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 24 Feb 2017to 8 May 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.
- Obtained informed consent from the subject.
- The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- The subject shall be healthy and compliant with good oral hygiene.
- Full-mouth bleeding score (FMBS) lower than 25% [10].
- Full-mouth plaque score (FMPI) lower than 20% [11].
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- Suitable for implant treatment in the posterior, pre-molar and canine area in the mandible or maxilla.
- The subject shall have a favorable and stable occlusal relationship.
- In need of one or multiple single tooth replacements or 3-unit bridges.
- Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).
- The implant sites are free from infection and extraction remnants.
- The subject is suitable for a 1-stage surgical procedure.
- Sufficient amount of buccal and lingual keratinized mucosa.
- The subject has a sufficient amount of bone for placing NobelActive implants with a length of at least 8 mm.
- Primary implant stability as assessed by manual hand testing.
Who cannot join
- The subject is not able to give her/his informed consent of participating.
- Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.
- Infections in the planned implantation site or adjacent tissue.
- Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
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- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
- Alcohol or drug abuse as noted in subject records or in subject history.
- Smoking of >10 cigarettes/day.
- Fresh extraction sites (up to 6 weeks).
- Severe bruxism or other destructive habits.
- Pregnant or lactating women at the time of implant insertion.
- Previous bone augmentation (lateral and/or vertical).
- Soft tissue augmentation less than 2 months before implant placement.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Lithuania3 sites
Dental Clinic Auksteja
Kaunas, LT, 44275
Dental Clinic Auksteja
Kaunas, 44275
Vilnius Implantology Center
Vilnius, 01205
Netherlands1 site
Tandartspraktijk Staas & Bergmans
's-Hertogenbosch, 5216
About this study
Official title: An Open, Prospective, Multi-center Study Evaluating the On1 Concept on NobelActive Implants
A 1-year Clinical Investigation on the On1 Concept.
Read the detailed description
This open, prospective, multi-center clinical trial evaluates the On1 Concept for the treatment of patients in need for single tooth replacement or 3-unit bridges in the mandible or maxilla.
- Conditions
- Implant
- Being tested
- On1 Concept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On1 ConceptDevice
NobelActive implant placement with simultaneous On1 Base placement
| Study group | Role | What they receive |
|---|---|---|
| On1 Concept | Other | On1 Concept \& NobelActive implants Receives: Device: On1 Concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone remodeling
The change in the marginal bone level around the implants from baseline to 12-months of follow-up is measured on paired radiographs.
Measured: 12 months
Secondary outcomes (7)
Soft tissue outcome (soft tissue height)
The change in soft tissue height from baseline to 12-months of follow-up.
Measured: 12 months
Component Survival
Survival rates of implants as well as On1 components and prosthetics.
Measured: 12 months
Component Success
Success of implants as well as On1 components and prosthetics by clinical evaluation calculated in a cumulative success rate life table.
Measured: 12 months
Patient's pain perception (visual analogue score)
The patient's pain perception during the post surgery period is evaluated by the use of a visual analogue score.
Measured: 3 months
Patient's oral health related quality of life (OHIP-14)
The patient's oral health related quality of life is evaluated by the use of the OHIP-14 questionnaire.
Measured: 12 months
Patient's satisfaction with function & esthetics (visual analogue score)
The patient's satisfaction with function \& esthetics is evaluated by the use of a visual analogue score.
Measured: 12 months
Ease of use of the On1 Concept (questionnaire)
The ease of use of the On1 Concept is evaluated by the use of a surgeon questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start24 Feb 2017
- Primary completion8 May 2019
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alina Gologan, DMD, Study director, Nobel Bioacare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100448
- Sponsor's protocol ID
- T-190
- Acronym
- T-190
- Status last verified
- Oct 2019
- First submitted
- 28 Feb 2017
- Last updated
- 1 Feb 2021
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multi-center Study Evaluating the On1 Concept on NobelActive Implants
- ClinicalTrials.gov ID
- NCT03100448
- Acronym / sponsor ID
- T-190 / T-190
- Conditions
- Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 4 Apr 2017 (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.
A 1-year Clinical Investigation on the On1 Concept.
Detailed description
This open, prospective, multi-center clinical trial evaluates the On1 Concept for the treatment of patients in need for single tooth replacement or 3-unit bridges in the mandible or maxilla.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On1 Concept | Other | Device: On1 ConceptOn1 Concept \& NobelActive implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.
- Obtained informed consent from the subject.
- The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- The subject shall be healthy and compliant with good oral hygiene.
- Full-mouth bleeding score (FMBS) lower than 25% [10].
Key exclusion criteria (15 listed)
- The subject is not able to give her/his informed consent of participating.
- Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.
- Infections in the planned implantation site or adjacent tissue.
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 |
|---|---|---|
| On1 ConceptNobelActive implant placement with simultaneous On1 Base placement | Device | On1 Concept |
Primary outcome
Marginal bone remodeling
Time frame: 12 months
The change in the marginal bone level around the implants from baseline to 12-months of follow-up is measured on paired radiographs.
7 secondary outcomes
Soft tissue outcome (soft tissue height)
Time frame: 12 months
Component Survival
Time frame: 12 months
Component Success
Time frame: 12 months
Patient's pain perception (visual analogue score)
Time frame: 3 months
Patient's oral health related quality of life (OHIP-14)
Time frame: 12 months
Patient's satisfaction with function & esthetics (visual analogue score)
Time frame: 12 months
Ease of use of the On1 Concept (questionnaire)
Time frame: 12 months
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 1 Feb 2021.
- 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.
Alina Gologan, DMD study director
Nobel Bioacare
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On1 Concept in people with Implant, run by Nobel Biocare at 6 sites in 4 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 15 inclusion and 15 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Lithuania, Belgium, 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 remodeling (time frame: 12 months). 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 1 Feb 2021.