to Study Soft Tissue Health and StabilityNCT04383834
A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________
An observational study of to Study Soft Tissue Health and Stability, run by Giacomo Fabbri at 1 site in Italy.
Trial summary
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- to Study Soft Tissue Health and Stability
- What is being tested?
- NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 1 May 2023
- How long will I take part?
- 47 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects, at least 18 years old, in need of one single restoration in the posterior region of the maxilla and/or the mandible.
Who may be able to join
- .The subject inclusion criteria are listed below. 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]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla.
- The subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement 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 healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems.
- The subject has a sufficient amount of bone for placing NobelActive TiUltra with a length of at least 7 mm.
- The following subject inclusion criteria apply at time of surgery:
- 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.
- 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 less 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. Subject has allergic or adverse reactions to the restorative material
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Studio Ban Mancini Fabbri
Cattolica, Rimini, 47841
Giacomo Fabbri, Dentista, 3473167583, info@bmf.dental
About this study
Official title: 2017-1538: A 3-years Investigator Initiated Study to Evaluate the Soft Tissue Health and Stability in the Mandible and/or Maxilla Using the NobelActive® TiUltra™ and On1™ Base/Xeal™
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
- Being tested
- NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 componentsDevice
The NobelActive® TiUltra™ implant is an ultra-hydrophilic multi-zone anodized implant surface. NobelActive® TiUltra™ features a gradual change in topography, from a minimally rough non-porous nanostructured implant collar to a moderately rough porous apex: more than roughness. NobelActive® TiUltra™ collar features surface chemistry and topography that promote early osseointegration and are designed to support bone stability. In addition, the Protective Layer preserves the pristine surface chemistry and hydrophilicity.
The second new product is the Base/Xeal™ new surface, which is covered by a titanium oxide layer, created by electrochemical anodization of a titanium machined component, resulting in a yellow hue nano-structured surface.
What is being measured
The primary outcome is the main question the study is designed to answer.
A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
Measured: 47 months (8 months enrolment + 36 months follow up + 3 months study closure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Study Soft Tissue Health and StabilityStudies 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
- Prospective
- Enrolment
- 58 participants (estimated)
- Target duration
- 47 Months
Sponsor and investigators
- Lead sponsor
- Giacomo Fabbri
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Giacomo Fabbri, Studio Ban Mancini Fabbri
- Investigators
- Giacomo Fabbri, Dentist, Principal investigator, Studio Ban Mancini Fabbri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383834
- Sponsor's protocol ID
- 2017-1538
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 12 May 2020
- Results posted
- 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 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2017-1538: A 3-years Investigator Initiated Study to Evaluate the Soft Tissue Health and Stability in the Mandible and/or Maxilla Using the NobelActive® TiUltra™ and On1™ Base/Xeal™
- ClinicalTrials.gov ID
- NCT04383834
- Acronym / sponsor ID
- 2017-1538
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Giacomo FabbriResearch network
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 12 May 2020 (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.
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 47 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects, at least 18 years old, in need of one single restoration in the posterior region of the maxilla and/or the mandible.
Key inclusion criteria (8 listed)
- .The subject inclusion criteria are listed below. 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]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla.
- The subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement 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 healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems.
Key exclusion criteria (7 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. Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).
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 |
|---|---|---|
| NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 componentsThe NobelActive® TiUltra™ implant is an ultra-hydrophilic multi-zone anodized implant surface. NobelActive® TiUltra™ features a gradual change in topography, from a minimally rough non-porous nanostructured implant collar to a moderately rough porous apex: more than roughness. NobelActive® TiUltra™ collar features surface chemistry and topography that promote early osseointegration and are designed to support bone stability. In addition, the Protective Layer preserves the pristine surface chemistry and hydrophilicity. The second new product is the Base/Xeal™ new surface, which is covered by a titanium oxide layer, created by electrochemical anodization of a titanium machined component, resulting in a yellow hue nano-structured surface. | Device | – |
Primary outcome
A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™
Time frame: 47 months (8 months enrolment + 36 months follow up + 3 months study closure)
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: No
Related trials for to Study Soft Tissue Health and Stability
Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
Osseointegration Failure of Dental Implant, Periimplantitis
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.
Giacomo Fabbri, Dentist principal investigator
Studio Ban Mancini Fabbri
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 to Study Soft Tissue Health and Stability, run by Giacomo Fabbri at 1 site in Italy.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 May 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Fabbri, Dentist (0039541963434, info@bmf.dental), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™ (time frame: 47 months (8 months enrolment + 36 months follow up + 3 months study closure)). 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 12 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.