Marginal Bone Level ChangeNCT04737421
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
An observational study of Marginal Bone Level Change, run by Nobel Biocare at 32 sites in 14 countries.
Trial summary
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Marginal Bone Level Change
- What is being tested?
- NobelActive TiUltra implant, NobelParallel CC TiUltra implants and NobelReplace CC TiUltra implants
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 32 sitesin 14 countries
- Study dates
- 26 May 2021to 31 May 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement. If the subject wishes to withdraw from the clinical study, he/she may do so at any time and for any reason during the clinical study. If provided, the reason for withdrawal should be recorded and documented in the subject's medical record and in the eCRF.
Who may be able to join
- Subject signed the informed consent
- Subject is between 18 and 70 years of age
- Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
- Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
- Subject with sufficient bone volume for implant placement.
- Subject is compliant with good oral hygiene as judged by the clinician.
Who cannot join
- Anatomical conditions discovered during surgery preventing the use of intended implant system.
- Subjects with history of allergy or adverse reactions to any materials used
- Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)*
- Heavy smokers (>10 cigarettes per day)
- Severe bruxism or dysfunctional tendencies
- Previous oro-maxillo facial radiotheraphy
Show all 12Show fewer
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
- Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- Infections in the planned implantation site or adjacent tissue.
- Documented complete remission of >3 years if history of non-oral cancer.
- Pregnant or lactating women at the time of implant insertion. *Assessment of A1C level is not required unless it is standard of care at the treating clinic
Trial locations and contacts
32 sites in 14 countries.
32 sites in 14 countries
United States5 sites
Northwest Oral and Maxillofacial Surgery
Arlington Heights, Illinois, 60005
Madison Prosthodontics
Madison, Alabama, 35758
New York Center for Orthognathic and Maxillofacial Surgery
New York, New York, 10022
Midwest Dental Implantology
Saint Charles, Illinois, 60174
Periodontal Associates
Tualatin, Oregon, 97062
Switzerland4 sites
Dentalspecialist
Egerkingen, 4622
Brunner Praxis für Zahnmedizin
Lucerne, 6003
Centrella Zahnärzte
Oberrieden, 8942
Bodensee-Implantat-Zentrum AG
Rorschach, 9400
Australia3 sites
Melbourne Dental School The University of Melbourne
Melbourne, 3010
Dentartisans Pty ltd
Pyrmont, New South Wales, 2009
Bc Prosthodontics
West Perth, Perth, 6005
France3 sites
Cabinet du Dr Noharet
Lyon, 69002
BGLP
Montpellier, 34090
IFCIA
Paris, 75017
Netherlands3 sites
Staas & Bergmans Zorgvooruwmond B.V.
's-Hertogenbosch, 5216
ParoBrea- Parodontologie & Implantologie
Breda, 4819
Department of Oral and Maxillofacial Surgery University Medical Center Groningen
Groningen, 9713
Spain3 sites
Clinica Lluch
Barcelona, 08006
Clinica Dental Crooke & Laguna
Málaga, 29016
Altés & Mesquida
Palma de Mallorca, 07004
Austria2 sites
Akademie für orale Implantologie GmbH & Co
Vienna, 1090
Implantologie und Ästhetische Zahnheilkunde
Vienna, 1190
Italy2 sites
Studio Odontoiatrico Specialistico Ban Mancini Fabbri
Cattolica, 47841
UOC di Chirurgia Maxillo-Facciale e Odontoiatria
Verona, 37134
Sweden2 sites
Folktandvården Västra Götaland, Brånemarkkliniken
Gothenburg, 413 90
Pequrio AB
Malmö, 217 72
Germany1 site
DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik
Karlstadt am Main, 97753
About this study
Official title: A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
Read the detailed description
Primary Objective: The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
Secondary Objective:The secondary objectives of this clinical investigation are:
- To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
- To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
- To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
- To evaluate soft tissue outcome (as measured by bleeding index, plaque index and gingival index) to 5 years from definitive prosthetic placement.
- To evaluate SADE, USADE, ADE and DD from implant insertion until 5 years follow-up visit.
Study design: This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The study devices are divided into four groups:
- Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)
- Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)
- Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)
- Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)
Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement . Possible dropouts and withdrawals, as well as possible serious adverse (device) events, will be carefully monitored during the entire study period
Sequence of treatment: As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study. Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject. Standard of care follow-up visits should be scheduled as close as possible to 1-, 3- and 5- years after definitive prosthetic placement, to ascertain a homogenous data set. Deidentified periapical radiographs from each subject visit shall be uploaded to the study eCRF. All images will be forwarded to the core lab for independent analysis. As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study.
Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject.
Study duration: Once the subject has provided written informed consent and fulfilled all inclusion and none of the exclusion criteria, he/she is considered enrolled. Subject enrolment period is expected to take 7 months from time of initiation at each site. Enrolment in each group will stop once the total group size of 250 subjects has been met. The clinical investigation will continue until each subject has been followed for 5-years after final prosthetic delivery.
- Conditions
- Marginal Bone Level Change
- Being tested
- NobelActive TiUltra implant, NobelParallel CC TiUltra implants, NobelReplace CC TiUltra implants, Nobel Biocare N1 TiUltra TCC implants
- Keywords
- bone remodelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelActive TiUltra implantDevice
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
NobelParallel CC TiUltra implantsDevice
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
NobelReplace CC TiUltra implantsDevice
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
Nobel Biocare N1 TiUltra TCC implantsDevice
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP) | Subjects will be enrolled into Group 1 and treated with NobelActive TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Receives: Device: NobelActive TiUltra implant | |
| Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP) | Subjects will be enrolled into Group 1 and treated with NobelParallel CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Receives: Device: NobelParallel CC TiUltra implants | |
| Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP) | Subjects will be enrolled into Group 1 and treated with NobelReplace CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Receives: Device: NobelReplace CC TiUltra implants | |
| Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP) | Subjects will be enrolled into Group 1 and treated with Nobel Biocare N1 TiUltra TCC implants , only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Receives: Device: Nobel Biocare N1 TiUltra TCC implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level change
The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
Measured: Definitive prosthetic delivery to 5-years follow-up
Secondary outcomes (7)
Marginal bone level change
To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
Measured: Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
Cumulative Survival rate/Cumulative success rate
To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
Measured: Definitive prosthetic delivery to 5-year follow-up
Prsothetic suviival and success rate
To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
Measured: Definitive prosthetic delivery to 5-years follow-up
Sost tissue outcome- Bleeding index
To evaluate soft tissue outcome as measured by bleeding index from definitive prosthetic placement to 5 years follow-up visit
Measured: Definitive prosthetic delivery to 5-years follow-up
Sost tissue outcome- Plaque index
To evaluate soft tissue outcome as measured by plaque index from definitive prosthetic placement to 5 years follow-up visit.
Measured: Definitive prosthetic delivery to 5-years follow-up
Sost tissue outcome- Ginigval index
To evaluate soft tissue outcome as measured by gingival index from definitive prosthetic placement to 5 years follow-up visit
Measured: Definitive prosthetic delivery to 5-years follow-up
Adverse event
To evaluate Serious Adverse Device Effects , Unanticipated Serious Adverse Device Effect , Adverse Device Effects and Device Deficiency from implant insertion until 5 years follow-up visit.
Measured: Implant insertion to 5-years follow-up
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 start26 May 2021
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone Level ChangeStudies 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
- 1,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737421
- Sponsor's protocol ID
- T-192
- Status last verified
- May 2025
- First submitted
- 28 Jan 2021
- Last updated
- 25 May 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
- ClinicalTrials.gov ID
- NCT04737421
- Acronym / sponsor ID
- T-192
- Conditions
- Marginal Bone Level Change
- Keywords
- bone remodelling
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- 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.
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
Detailed description
Primary Objective: The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
Secondary Objective:The secondary objectives of this clinical investigation are:
- To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
- To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
- To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
- To evaluate soft tissue outcome (as measured by bleeding index, plaque index and gingival index) to 5 years from definitive prosthetic placement.
- To evaluate SADE, USADE, ADE and DD from implant insertion until 5 years follow-up visit.
Study design: This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The study devices are divided into four groups:
- Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)
- Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)
- Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)
- Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)
Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement . Possible dropouts and withdrawals, as well as possible serious adverse (device) events, will be carefully monitored during the entire study period
Sequence of treatment: As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study. Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject. Standard of care follow-up visits should be scheduled as close as possible to 1-, 3- and 5- years after definitive prosthetic placement, to ascertain a homogenous data set. Deidentified periapical radiographs from each subject visit shall be uploaded to the study eCRF. All images will be forwarded to the core lab for independent analysis. As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study.
Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject.
Study duration: Once the subject has provided written informed consent and fulfilled all inclusion and none of the exclusion criteria, he/she is considered enrolled. Subject enrolment period is expected to take 7 months from time of initiation at each site. Enrolment in each group will stop once the total group size of 250 subjects has been met. The clinical investigation will continue until each subject has been followed for 5-years after final prosthetic delivery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP) | – | Device: NobelActive TiUltra implantSubjects will be enrolled into Group 1 and treated with NobelActive TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
| Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP) | – | Device: NobelParallel CC TiUltra implantsSubjects will be enrolled into Group 1 and treated with NobelParallel CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
| Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP) | – | Device: NobelReplace CC TiUltra implantsSubjects will be enrolled into Group 1 and treated with NobelReplace CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
| Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP) | – | Device: Nobel Biocare N1 TiUltra TCC implantsSubjects will be enrolled into Group 1 and treated with Nobel Biocare N1 TiUltra TCC implants , only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement. If the subject wishes to withdraw from the clinical study, he/she may do so at any time and for any reason during the clinical study. If provided, the reason for withdrawal should be recorded and documented in the subject's medical record and in the eCRF.
Key inclusion criteria (6 listed)
- Subject signed the informed consent
- Subject is between 18 and 70 years of age
- Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
- Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
- Subject with sufficient bone volume for implant placement.
Key exclusion criteria (12 listed)
- Anatomical conditions discovered during surgery preventing the use of intended implant system.
- Subjects with history of allergy or adverse reactions to any materials used
- Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)*
- Heavy smokers (>10 cigarettes per day)
- Severe bruxism or dysfunctional tendencies
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 implantSubjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. | Device | Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP) |
| NobelParallel CC TiUltra implantsSubjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. | Device | Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP) |
| NobelReplace CC TiUltra implantsSubjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. | Device | Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP) |
| Nobel Biocare N1 TiUltra TCC implantsSubjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. | Device | Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP) |
Primary outcome
Marginal bone level change
Time frame: Definitive prosthetic delivery to 5-years follow-up
The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
7 secondary outcomes
Marginal bone level change
Time frame: Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
Cumulative Survival rate/Cumulative success rate
Time frame: Definitive prosthetic delivery to 5-year follow-up
Prsothetic suviival and success rate
Time frame: Definitive prosthetic delivery to 5-years follow-up
Sost tissue outcome- Bleeding index
Time frame: Definitive prosthetic delivery to 5-years follow-up
Sost tissue outcome- Plaque index
Time frame: Definitive prosthetic delivery to 5-years follow-up
Sost tissue outcome- Ginigval index
Time frame: Definitive prosthetic delivery to 5-years follow-up
Adverse event
Time frame: Implant insertion to 5-years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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.
32 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marginal Bone Level Change, run by Nobel Biocare at 32 sites in 14 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Switzerland, Australia, France, Netherlands and 9 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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 change (time frame: Definitive prosthetic delivery to 5-years follow-up). 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 25 May 2025.