Single Tooth ImplantNA 3 MMNCT02184845
A 5 Year Clinical Study on NobelActive 3 mm Implants
A study testing Implant NobelActive 3.0 in people with Single Tooth Implant, run by Nobel Biocare.
Trial summary
Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Tooth Implant
- What is being tested?
- Implant NobelActive 3.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to 5 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtained informed consent from the subject.
- The subject shall be at least 18 years of age and have passed secession of growth.
- The subject shall be in need of one or more single tooth implant supported restoration(s) in the maxillary lateral incisor or mandibular central or lateral incisor areas of the mouth.
- The subject shall have natural tooth roots present on both sides adjacent to the implant position.
- The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
- The subject shall have sufficient bone volume at the implant site for placing a NobelActive 3.0 mm implant with a length of at least 10 mm.
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- The subject as well as the implant site shall fulfill criteria for immediate provisionalization within 24 hours. A minimum insertion torque of 35 Ncm without further rotation is required.
- The implant site shall be free from tooth remnants.
- If the implant is placed in an extraction site, the extraction socket should have at least 3 intact walls. A dehiscence defect of up to 3 mm is permitted on the fourth wall.
- If the implant is placed in an extraction site, proper and thorough debridement of the extraction socket should be performed.
- The subject shall be healthy and compliant with good oral hygiene.
- The subject shall have a favorable and stable occlusal relationship.
Who cannot join
- The subject is not able to give her/his informed consent of participating
- Health conditions, which do not permit the surgical treatment.
- Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history.
- Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation.
- Teeth in positions adjacent to the implant site with ongoing infections, endodontic or peri-odontal problems.
- Alcohol or drug abuse as noted in subject records or in subject history.
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- Heavy smoking (>10 cigarettes/day).
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake.
- Any other disease or medication that might have an influence on the involved tissues, such as intake of bisphosphonates, treatment with heparine, osteogenesis imperfecta, osteoporosis etc.
- Severe bruxism or other destructive habits.
- If the implant is not able to withstand a final torque of 35 Ncm without further rotation, or if the implant for any other reason cannot be immediately provisionalized, as judged by the clinician, the implant will be excluded from the study.
About this study
Official title: Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelActive 3 mm Implant Immediately Restored With Single Crowns in the Maxillary Lateral Incisor Area or Mandibular Central or Lateral Incisor Area
Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.
- Conditions
- Single Tooth Implant
- Being tested
- Implant NobelActive 3.0
- Keywords
- single tooth implant, supported restoration(s), maxillary lateral incisor, mandibular central incisor, lateral incisor, areas of the mouth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant NobelActive 3.0Device
| Study group | Role | What they receive |
|---|---|---|
| NobelActive 3.0 | Experimental | Not described Receives: Device: Implant NobelActive 3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level changes
Marginal bone level changes over time around the NobelActive 3.0 mm implant
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJan 2011
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
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 Single Tooth 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
- 77 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
- NCT02184845
- Sponsor's protocol ID
- T 176
- Acronym
- NA 3 MM
- Status last verified
- Nov 2020
- First submitted
- 3 Jul 2014
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Weigl P, Trimpou G, Hess P, Kolinski M, Bellucci G, Trisciuoglio D, Friberg B, Leziy S, Al-Nawas B, Wagner W, Pozzi A, Ottria L, Wiltfang J, Behrens E, Vasak C, Zechner W. Esthetically driven immediate provisionalization in the anterior zone: 5-year results from a prospective study evaluating 3.0-mm-diameter tapered implants. Clin Oral Investig. 2024 Jul 31;28(8):460. doi: 10.1007/s00784-024-05832-x.
PubMed 39083185
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelActive 3 mm Implant Immediately Restored With Single Crowns in the Maxillary Lateral Incisor Area or Mandibular Central or Lateral Incisor Area
- ClinicalTrials.gov ID
- NCT02184845
- Acronym / sponsor ID
- NA 3 MM / T 176
- Conditions
- Single Tooth Implant
- Keywords
- single tooth implant, supported restoration(s), maxillary lateral incisor, mandibular central incisor, lateral incisor, areas of the mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 9 Jul 2014 (estimated)
- 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.
Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NobelActive 3.0 | Experimental | Device: Implant NobelActive 3.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Obtained informed consent from the subject.
- The subject shall be at least 18 years of age and have passed secession of growth.
- The subject shall be in need of one or more single tooth implant supported restoration(s) in the maxillary lateral incisor or mandibular central or lateral incisor areas of the mouth.
- The subject shall have natural tooth roots present on both sides adjacent to the implant position.
- The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
Key exclusion criteria (11 listed)
- The subject is not able to give her/his informed consent of participating
- Health conditions, which do not permit the surgical treatment.
- Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history.
- Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation.
- Teeth in positions adjacent to the implant site with ongoing infections, endodontic or peri-odontal problems.
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 |
|---|---|---|
| Implant NobelActive 3.0 | Device | NobelActive 3.0 |
Primary outcome
Marginal bone level changes
Time frame: 5 years
Marginal bone level changes over time around the NobelActive 3.0 mm implant
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 3 Mar 2021.
- Derived from this study: PubMed 39083185Weigl P, Trimpou G, Hess P, Kolinski M, Bellucci G, Trisciuoglio D, Friberg B, Leziy S, Al-Nawas B, Wagner W, Pozzi A, Ottria L, Wiltfang J, Behrens E, Vasak C, Zechner W. Esthetically driven immediate provisionalization in the anterior zone: 5-year results from a prospective study evaluating 3.0-mm-diameter tapered implants. Clin Oral Investig. 2024 Jul 31;28(8):460. doi: 10.1007/s00784-024-05832-x.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Implant NobelActive 3.0 in people with Single Tooth Implant, 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 12 inclusion and 11 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 3 Mar 2021. 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?
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 changes (time frame: 5 years). 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 NCT02184845, 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 3 Mar 2021.