Surface FinishBiofilm2020NCT04181099
Influence of Different Zirconia Surface Treatments on Biofilm Formation
A study testing Implant neck surface in people with Surface Finish, run by University of Basel at 1 site in Switzerland.
Trial summary
The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surface Finish
- What is being tested?
- Implant neck surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to 1 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No systematic antibiotic therapy during the last 3 months
- Good oral health and compliance (PI and BI <20%)
- No sign of parodontal disease or other inflammatory changes in the mouth
- Non-smoker
Who cannot join
- Disease that requires antibiotic therapy
- Pressure marks due to the orthodontic apparatus that can not be eliminated
- Other unexpected complications that could be related to the orthodontic apparatus
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Center for Dental Medicine Basel
Basel, Canton of Basel-City, 4058
About this study
The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.
- Conditions
- Surface Finish
- Being tested
- Implant neck surface
- Keywords
- dental implant, zirconia, biofilm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant neck surfaceOther
The biofilm formation is tested on discs manufactured of zirconia with different surfaces in vivo using orthodontic devices that the participants carry over 24h
| Study group | Role | What they receive |
|---|---|---|
| Zirconia structure | Other | The participants will carry an orthodontic device containing 4 discs of differently structured zirconia and titanium to test the biofilm formation in order to determine the ideal structure for the neck area of zirconia dental implants. Receives: Other: Implant neck surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safranin Staining
The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer
Measured: 3 months
Secondary outcomes (1)
SEM
The morphology of the biofilm is analyzed using scanning electron microscopy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surface FinishStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Rohr, University of Basel
- Investigators
- Jens Fischer, Prof, Study director, University Center for Dental Medicine Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181099
- Sponsor's protocol ID
- 2019-01918
- Other IDs
- 2019
- Acronym
- Biofilm2020
- Status last verified
- Apr 2021
- First submitted
- 26 Nov 2019
- Last updated
- 28 Apr 2021
- 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Zirconia Surface Treatments on Biofilm Formation
- ClinicalTrials.gov ID
- NCT04181099
- Acronym / sponsor ID
- Biofilm2020 / 2019-01918
- Conditions
- Surface Finish
- Keywords
- dental implant, zirconia, biofilm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 29 Nov 2019 (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.
The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zirconia structure | Other | Other: Implant neck surfaceThe participants will carry an orthodontic device containing 4 discs of differently structured zirconia and titanium to test the biofilm formation in order to determine the ideal structure for the neck area of zirconia dental implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No systematic antibiotic therapy during the last 3 months
- Good oral health and compliance (PI and BI <20%)
- No sign of parodontal disease or other inflammatory changes in the mouth
- Non-smoker
Key exclusion criteria (3 listed)
- Disease that requires antibiotic therapy
- Pressure marks due to the orthodontic apparatus that can not be eliminated
- Other unexpected complications that could be related to the orthodontic apparatus
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 neck surfaceThe biofilm formation is tested on discs manufactured of zirconia with different surfaces in vivo using orthodontic devices that the participants carry over 24h | Other | Zirconia structure |
Primary outcome
Safranin Staining
Time frame: 3 months
The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer
1 secondary outcome
SEM
Time frame: 3 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 28 Apr 2021.
- 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.
Jens Fischer, Prof study director
University Center for Dental Medicine Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant neck surface in people with Surface Finish, run by University of Basel at 1 site in Switzerland.
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 4 inclusion and 3 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 28 Apr 2021. 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 Switzerland. 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?
Safranin Staining (time frame: 3 months). 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 28 Apr 2021.