Biofilm FormationNCT03554876
Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components
A study testing Multi-Im Machined transepithelial component., Multi-Im Nanogolden transepithelial component and Multi-Im Ti-Golden transepithelial component in people with Biofilm Formation, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial summary
This study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion. The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biofilm Formation
- What is being tested?
- Multi-Im Machined transepithelial component., Multi-Im Nanogolden transepithelial component and Multi-Im Ti-Golden transepithelial component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jul 2018to 22 Dec 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
- Indication of having to place at least three dental implants.
- Plate index ≤ 20% and absence of evidence of active periodontal disease.
- Bleeding index of adjacent teeth ≤ 30%.
- Probing depth in adjacent teeth <4 mm.
- Not having used systemic antibiotics during the last 6 months.
- Non smoker.
- Possibility for observation during the treatment period.
- Having signed the informed consent.
Who cannot join
- Suffering any alteration or serious hematologic disease.
- Being undergoing or having received in the 30 days prior to inclusion:
- radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants.
- Presence of malignant tumors, hemangiomas or angiomas in the area of implant placement.
- Patients undergoing treatment with bisphosphonate drugs, both orally and intravenously.
- Metabolic bone disease.
Show all 13Show fewer
- Diseases that affect the oral mucosa.
- Diabetic patients.
- Severe parafunctional habits and/or temporomandibular joint disorders.
- Pregnant or lactating women.
- Physical or mental inability to maintain a good oral hygiene.
- Being participating in another study.
- In general, any inability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components Placed on Implants
This study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion.
The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the Ti-Golden® surface (Multi-Im Golden) or with the nanogolden surface (Multi-Im® nanogolden). Periodontal indices and biofilformation will be assessed during 2 months after implant loading. Metagenomic analysis and PCR technique will be implemented to assess the biofilm formation.
- Conditions
- Biofilm Formation
- Being tested
- Multi-Im Machined transepithelial component., Multi-Im Nanogolden transepithelial component, Multi-Im Ti-Golden transepithelial component
- Keywords
- Biofilm, peri-implantitis, metagenomic analysis, abutment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Im Machined transepithelial component.Device
Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM machined transepithelial component is connected to the implant.
Multi-Im Nanogolden transepithelial componentDevice
Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Nanogolden transepithelial component is connected to the implant.
Multi-Im Ti-Golden transepithelial componentDevice
Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Ti-Golden transepithelial component is connected to the implant.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Im Machined | Active comparator | Multi-Im Machined Receives: Device: Multi-Im Machined transepithelial component. |
| Multi-Im® nanogolden | Experimental | Multi-Im® nanogolden Receives: Device: Multi-Im Nanogolden transepithelial component |
| Multi-Im T-Golden | Experimental | Multi-Im T-Golden Receives: Device: Multi-Im Ti-Golden transepithelial component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants
Measured: 24 hours
Total amount of the 25 most relevant bacterial species in peri-implantitis processes
Measured: 2 months
Secondary outcomes (5)
Total number of bacterial species.
Measured: 24 hours, 2 months
Total amount of the 6 most abundant bacterial species.
Measured: 24 hours, 2 months
Dental plaque index
Measured: Baseline, 24 hours, 2 months
Gingival index of the natural teeth
Measured: Baseline, 24 hours, 2 months
Probing depth of natural teeth
Measured: Baseline, 24 hours, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start16 Jul 2018
- Primary completion22 Dec 2020
- Study completion22 Dec 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 Biofilm FormationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554876
- Sponsor's protocol ID
- FIBEA-06-EC/17/Multi-Im
- Status last verified
- Feb 2025
- First submitted
- 30 May 2018
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anitua E, Murias-Freijo A, Tierno R, Tejero R, Alkhraisat MH. Assessing peri-implant bacterial community structure: the effect of microbiome sample collection method. BMC Oral Health. 2024 Aug 26;24(1):1001. doi: 10.1186/s12903-024-04675-y.
PubMed 39187802
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components Placed on Implants
- ClinicalTrials.gov ID
- NCT03554876
- Acronym / sponsor ID
- FIBEA-06-EC/17/Multi-Im
- Conditions
- Biofilm Formation
- Keywords
- Biofilm, peri-implantitis, metagenomic analysis, abutment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 13 Jun 2018 (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 study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion.
The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the Ti-Golden® surface (Multi-Im Golden) or with the nanogolden surface (Multi-Im® nanogolden). Periodontal indices and biofilformation will be assessed during 2 months after implant loading. Metagenomic analysis and PCR technique will be implemented to assess the biofilm formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-Im Machined | Active comparator | Device: Multi-Im Machined transepithelial component.Multi-Im Machined |
| Multi-Im® nanogolden | Experimental | Device: Multi-Im Nanogolden transepithelial componentMulti-Im® nanogolden |
| Multi-Im T-Golden | Experimental | Device: Multi-Im Ti-Golden transepithelial componentMulti-Im T-Golden |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Indication of having to place at least three dental implants.
- Plate index ≤ 20% and absence of evidence of active periodontal disease.
- Bleeding index of adjacent teeth ≤ 30%.
- Probing depth in adjacent teeth <4 mm.
- Not having used systemic antibiotics during the last 6 months.
Key exclusion criteria (13 listed)
- Suffering any alteration or serious hematologic disease.
- Being undergoing or having received in the 30 days prior to inclusion:
- radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants.
- Presence of malignant tumors, hemangiomas or angiomas in the area of implant placement.
- Patients undergoing treatment with bisphosphonate drugs, both orally and intravenously.
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 |
|---|---|---|
| Multi-Im Machined transepithelial component.Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM machined transepithelial component is connected to the implant. | Device | Multi-Im Machined |
| Multi-Im Nanogolden transepithelial componentOnce the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Nanogolden transepithelial component is connected to the implant. | Device | Multi-Im® nanogolden |
| Multi-Im Ti-Golden transepithelial componentOnce the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Ti-Golden transepithelial component is connected to the implant. | Device | Multi-Im T-Golden |
Primary outcome
Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants
Time frame: 24 hours
Total amount of the 25 most relevant bacterial species in peri-implantitis processes
Time frame: 2 months
5 secondary outcomes
Total number of bacterial species.
Time frame: 24 hours, 2 months
Total amount of the 6 most abundant bacterial species.
Time frame: 24 hours, 2 months
Dental plaque index
Time frame: Baseline, 24 hours, 2 months
Gingival index of the natural teeth
Time frame: Baseline, 24 hours, 2 months
Probing depth of natural teeth
Time frame: Baseline, 24 hours, 2 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 25 Feb 2025.
- Derived from this study: PubMed 39187802Anitua E, Murias-Freijo A, Tierno R, Tejero R, Alkhraisat MH. Assessing peri-implant bacterial community structure: the effect of microbiome sample collection method. BMC Oral Health. 2024 Aug 26;24(1):1001. doi: 10.1186/s12903-024-04675-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Im Machined transepithelial component., Multi-Im Nanogolden transepithelial component and Multi-Im Ti-Golden transepithelial component in people with Biofilm Formation, run by Fundación Eduardo Anitua at 1 site in Spain.
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 13 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 25 Feb 2025. 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 Spain. 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?
Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT03554876, 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 25 Feb 2025.