Peri-implant Crevicular FluidExploratoryNCT06557447
An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces
A study testing Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation in people with Peri-implant Crevicular Fluid, run by Studio Ban Mancini Fabbri.
Trial summary
A total of 22 subjects will be included in the study. The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Crevicular Fluid
- What is being tested?
- Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Apr 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects willing to sign the Informed Consent Form
- Subjects able to adhere to the investigation schedule
- Subjects with no previous surgical intervention or soft tissue complications in the area of the implant site (e.g., localized mucositis, mild peri-implantitis, etc.) within 3 months before first sample collection
- Subjects regularly adhere to a professional oral hygiene maintenance program
- No recent antibiotics or biological therapy (or any treatment that activates or suppresses the immune system)
- No xerostomia
Who cannot join
- Subject not willing to sign the Informed Consent Form
- Subject not able to adhere to the investigation schedule
About this study
Official title: An Exploratory Clinical Investigation Evaluating Microbiological and Immunological Aspects of Peri-implant Crevicular Fluid and Short-term Treatment Outcomes of Two Different Implant Abutment Surfaces in Subjects Since Four to Nine Years
A total of 22 subjects will be included in the study. The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group. Two peri-implant crevicular fluid (PICF) samples will be collected for immunological testing and two plaques samples will be collected for microbiological testing from all the enrolled subjects one from the control/test implant site and one from the contralateral tooth/implant site. 3 weeks after the first sampling PICF and plaques sampling will be repeated the same way.
Read the detailed description
The main objective of the study is to evaluate the clinical, microbiological, and immunological biomarkers of implant sites which were treated with two different implant-abutment-systems (anodized surface and machined surface). This single-center exploratory study includes 22 subjects, divided into two distinct groups: Test group and Control group. All subjects in both groups have undergone treatment. In the Test group, subjects were treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment, while in the Control group, treatment occurred in 2017 with NobelActive TiUnite implant and On1 machined abutment. All subjects were treated by the same clinician, Dr Giacomo Fabbri, and were participants in two approved clinical study protocols (T-190 and IIT 2017-1538) approaved by local Ethics Committee. T-190, a multicenter study, involved 21 subjects from Dr Fabbri's center, with 12 subjects available for recall (Control group) in this study. The IIT 2017-1538 study included 61 subjects, with 12 subjects scheduled for recall (Test group) in the current study. Two subjects were part of both the studies, received both the implant abutment solutions and belong to both the groups. The subjects are enrolled provided they meet all the inclusion and none of the exclusion criteria and sign the informed consent. Peri-implant crevicular fluid (PICF) and plaques samples will be collected from control and test implant sites (and respective contralateral tooth/implants) of each participating subject for immunological and microbiological testing at two time points with an interval of approximately 3 weeks between the two sample collections.
- Conditions
- Peri-implant Crevicular Fluid
- Being tested
- Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluationDiagnostic test
Immunological sample collection involves placing a Periopaper strip in the peri-implantar sulcus for 30 seconds. If sample is contaminated with blood, sample will be discarded and another sample will be collected (a different surface of the same implant/tooth can be used).
Microbiological sample collection involves collecting subgingival dental plaque by sliding the end of the STERILE curette (Gracey) inside the peri-implant sulcus. In case of slight bleeding following the first sample, dry the site again before collection. In case of profuse bleeding, collect a sample from another site (by site mean mesial/buccal/distal/lingual) of the same implant.
Both immunological and microbiological samples will be sent for respective laboratories for the analysis.
Clinical evaluation will assess presence of dental plaque, bleeding on probing and gingival status.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Other | Subjects treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment on a previous clinical study protocol approaved by Ethics Committee. Receives: Diagnostic Test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation |
| Control Group | Other | Subjects treated in 2017 with NobelActive TiUnite implant and On1 machined abutment on a previous clinical study protocol approaved by Ethics Committee. Receives: Diagnostic Test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate immunological markers in peri-implant crevicular fluid
Immunological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group
Measured: 2 samples collections with 3 weeks of interval
Evaluate microbiological response in peri-implant crevicular fluid
Microbiological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group
Measured: 2 samples collections with 3 weeks of interval
Bleeding Index
Bleeding on probing will be assessed on implant and contralateral tooth/implant for test and control group
Measured: Pre-treatment/initial visit
Gingival Index
Gingival status will be assessed on implant and contralateral tooth/implant for test and control group
Measured: Pre-treatment/initial visit
Plaque Index
Dental plaque will be assessed on implant and contralateral tooth/implant for test and control group
Measured: Pre-treatment/initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startDec 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Crevicular FluidStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory study
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Studio Ban Mancini Fabbri
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557447
- Sponsor's protocol ID
- Efontanarosa
- Acronym
- Exploratory
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Investigation Evaluating Microbiological and Immunological Aspects of Peri-implant Crevicular Fluid and Short-term Treatment Outcomes of Two Different Implant Abutment Surfaces in Subjects Since Four to Nine Years
- ClinicalTrials.gov ID
- NCT06557447
- Acronym / sponsor ID
- Exploratory / Efontanarosa
- Conditions
- Peri-implant Crevicular Fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Studio Ban Mancini FabbriResearch network
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 16 Aug 2024 (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 total of 22 subjects will be included in the study. The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group. Two peri-implant crevicular fluid (PICF) samples will be collected for immunological testing and two plaques samples will be collected for microbiological testing from all the enrolled subjects one from the control/test implant site and one from the contralateral tooth/implant site. 3 weeks after the first sampling PICF and plaques sampling will be repeated the same way.
Detailed description
The main objective of the study is to evaluate the clinical, microbiological, and immunological biomarkers of implant sites which were treated with two different implant-abutment-systems (anodized surface and machined surface). This single-center exploratory study includes 22 subjects, divided into two distinct groups: Test group and Control group. All subjects in both groups have undergone treatment. In the Test group, subjects were treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment, while in the Control group, treatment occurred in 2017 with NobelActive TiUnite implant and On1 machined abutment. All subjects were treated by the same clinician, Dr Giacomo Fabbri, and were participants in two approved clinical study protocols (T-190 and IIT 2017-1538) approaved by local Ethics Committee. T-190, a multicenter study, involved 21 subjects from Dr Fabbri's center, with 12 subjects available for recall (Control group) in this study. The IIT 2017-1538 study included 61 subjects, with 12 subjects scheduled for recall (Test group) in the current study. Two subjects were part of both the studies, received both the implant abutment solutions and belong to both the groups. The subjects are enrolled provided they meet all the inclusion and none of the exclusion criteria and sign the informed consent. Peri-implant crevicular fluid (PICF) and plaques samples will be collected from control and test implant sites (and respective contralateral tooth/implants) of each participating subject for immunological and microbiological testing at two time points with an interval of approximately 3 weeks between the two sample collections.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory study
| Arm | Type | Receives |
|---|---|---|
| Test Group | Other | Diagnostic Test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluationSubjects treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment on a previous clinical study protocol approaved by Ethics Committee. |
| Control Group | Other | Diagnostic Test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluationSubjects treated in 2017 with NobelActive TiUnite implant and On1 machined abutment on a previous clinical study protocol approaved by Ethics Committee. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects willing to sign the Informed Consent Form
- Subjects able to adhere to the investigation schedule
- Subjects with no previous surgical intervention or soft tissue complications in the area of the implant site (e.g., localized mucositis, mild peri-implantitis, etc.) within 3 months before first sample collection
- Subjects regularly adhere to a professional oral hygiene maintenance program
- No recent antibiotics or biological therapy (or any treatment that activates or suppresses the immune system)
Key exclusion criteria (2 listed)
- Subject not willing to sign the Informed Consent Form
- Subject not able to adhere to the investigation schedule
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 |
|---|---|---|
| Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluationImmunological sample collection involves placing a Periopaper strip in the peri-implantar sulcus for 30 seconds. If sample is contaminated with blood, sample will be discarded and another sample will be collected (a different surface of the same implant/tooth can be used). Microbiological sample collection involves collecting subgingival dental plaque by sliding the end of the STERILE curette (Gracey) inside the peri-implant sulcus. In case of slight bleeding following the first sample, dry the site again before collection. In case of profuse bleeding, collect a sample from another site (by site mean mesial/buccal/distal/lingual) of the same implant. Both immunological and microbiological samples will be sent for respective laboratories for the analysis. Clinical evaluation will assess presence of dental plaque, bleeding on probing and gingival status. | Diagnostic test | Control Group, Test Group |
Primary outcome
Evaluate immunological markers in peri-implant crevicular fluid
Time frame: 2 samples collections with 3 weeks of interval
Immunological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group
Evaluate microbiological response in peri-implant crevicular fluid
Time frame: 2 samples collections with 3 weeks of interval
Microbiological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group
Bleeding Index
Time frame: Pre-treatment/initial visit
Bleeding on probing will be assessed on implant and contralateral tooth/implant for test and control group
Gingival Index
Time frame: Pre-treatment/initial visit
Gingival status will be assessed on implant and contralateral tooth/implant for test and control group
Plaque Index
Time frame: Pre-treatment/initial visit
Dental plaque will be assessed on implant and contralateral tooth/implant for test and control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation in people with Peri-implant Crevicular Fluid, run by Studio Ban Mancini Fabbri.
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 2 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 16 Aug 2024. 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?
Results are not available in the source record.
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?
Evaluate immunological markers in peri-implant crevicular fluid (time frame: 2 samples collections with 3 weeks of interval). The study lists 5 primary outcomes in all. 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 16 Aug 2024.