Dental PlaqueNCT05122897
Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns
A study testing Rings made of PA (test) in people with Dental Plaque and Oral Biofilm, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This in-vivo study investigates early (48h), mature (2 weeks) and long-term (3 months) biofilm formation and composition on temporary push-on cones (exchangeable conical rings) made of noble-alloy-based materials (Pagalinor, PA) in comparison to Titanium-6Aluminum-7Niobium alloy (TAN) presently used in the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Oral Biofilm, Peri-implantitis
- What is being tested?
- Rings made of PA (test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jan 2022to 31 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- Presence of one or more bone level titanium implant prior to insertion of the final restoration
- No systemic illness
- No heavy smoking (smoking <10 cigarettes/day)
- No pregnancy
- No active periodontitis (probing pocket depth ≤4 mm)
- No pharmacological treatment or antibiotic therapy during or up to three months before the study
Who cannot join
- Systemic illness (e.g. Diabetes)
- Heavy smoking (smoking >10 cigarettes/day)
- Known or suspected non-compliance, drug or alcohol abuse
- Pregnancy
- Active periodontitis (probing pocket depth >4 mm)
- Pharmacological treatment or antibiotic therapy during or up to three months before the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
UZB (University Center for Dental Medicine Basel)
Basel, 4058
Nicola U. Zitzmann, Prof. Dr., +41 61 267 26 36, n.zitzmann@unibas.ch
Lucia K. Zaugg, Dr. med. dent., +41 61 267 26 36, lucia.zaugg@unibas.ch
About this study
Official title: Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation
This in-vivo study investigates early (48h), mature (2 weeks) and long-term (3 months) biofilm formation and composition on temporary push-on cones (exchangeable conical rings) made of noble-alloy-based materials (Pagalinor, PA) in comparison to Titanium-6Aluminum-7Niobium alloy (TAN) presently used in the transmucosal portion of dental implant abutments.
Read the detailed description
Oral biofilm (dental plaque) consists of bacteria and their metabolic products as well as saliva components and food residues. It is recognizable as a tough and structured coating on teeth and artificial surfaces within the oral cavity. Plaque development is a physiological process that begins immediately after cleaning of the oral surface. If the biofilm is not removed by daily oral hygiene, it continues to mature while changing the structure and its microbial composition.
Implant restorations comprise the osseous implant portion predominantly manufactured from titanium alloys, the transmucosal implant portion (in most implant systems as a separate abutment), and the clinical crown, which is in most systems extraorally cemented on an abutment and screw-retained onto the implant. According to current knowledge, microbial colonization of the implant abutment surface plays a significant role in the aetiology of peri-implantitis.
This study investigates the antibacterial potential of a temporary push-on cone (conical ring) that could reduce the risk of bacterial related peri-implant diseases due to decreased biofilm susceptibility, compared to current available transmucosal materials, in the short- and long-run. The test material Pagalinor®2 (PA) is an established material in dental medicine and has proven to accumulate least biofilm in an in-vivo biofilm sampling model using removable splints. The control material consists of the current transmucosal implant abutment material Titanium-6Aluminum- 7Niobium alloy (TAN). The push-on rings are designed for repeated application along the transmucosal implant abutment portion with high precision fit and will allow biofilm sampling in the natural implant environment. Profound insight into the native homeostasis of biofilm formation will be obtained and therefore enhance the knowledge about long-term tissue response.
- Conditions
- Dental Plaque, Oral Biofilm, Peri-implantitis
- Being tested
- Rings made of PA (test), Rings made of TAN (control)
- Keywords
- Titanium-6Aluminum-7Niobium alloy, Pagalinor, transmucosal implant abutment, implant crowns, temporary push-on rings, Variobase abutments
- Medical subject headings
- Dental Plaque, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rings made of PA (test)Device
Rings made of PA (test) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Test rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period).
Rings made of TAN (control)Device
Rings made of TAN (control) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Control rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period).
| Study group | Role | What they receive |
|---|---|---|
| Pagalinor®2 (PA) test arm | Experimental | All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner. Receives: Device: Rings made of PA (test) |
| Titanium-6Aluminum- 7Niobium alloy (TAN) control arm | Active comparator | All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner. Receives: Device: Rings made of TAN (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total bacterial load formed on the removable rings of each material
Quantification of the bacterial load formed on the removable rings of each material by quantitative real-time PCR (qPCR) using primers specific to highly conserved regions of bacterial 16S rRNA genes.
Measured: at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placement
Secondary outcomes (5)
Change in bacterial composition (taxonomic diversity) between different materials at various time points by using metagenomic sequencing analysis
To assess differences in bacterial composition (taxonomic diversity) between different materials at various time points by Illumina MiSeq sequencing. The taxonomy of each 16S rRNA gene sequence will be analyzed by Ribosomal Database Project (RDP) Classifier (http://rdp.cme.msu.edu/) against the SILVA (SSU123) 16S rRNA database using a confidence threshold of 70%.
Measured: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in probing pocket depth (PPD) in mm
Change in probing pocket depth (PPD) to investigate the inflammatory tissue response
Measured: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in bleeding on probing (BoP)
Recording bleeding on probing (BoP) to investigate the inflammatory tissue response
Measured: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in noninvasive laser doppler flowmetry
Change in noninvasive laser doppler flowmetry to to measure the blood flow of mucosa next to the ring
Measured: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in the cells of the peri-implant soft tissue
To investigate the attachment of peri-implant soft tissues to implant materials, fibroblasts and junctional epithelial cells markers will be analysed using real-time quantitative PCR (RT-qPCR).
Measured: at 2 weeks after ring placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start11 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients enrolled in the current investigation will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
- Investigators
- Nicola U. Zitzmann, Prof. Dr., Principal investigator, University Center for Dental Medicine Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122897
- Sponsor's protocol ID
- 2021-D0061; ex21Zitzmann
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation
- ClinicalTrials.gov ID
- NCT05122897
- Acronym / sponsor ID
- 2021-D0061; ex21Zitzmann
- Conditions
- Dental Plaque, Oral Biofilm, Peri-implantitis
- Keywords
- Titanium-6Aluminum-7Niobium alloy, Pagalinor, transmucosal implant abutment, implant crowns, temporary push-on rings, Variobase abutments
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 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 in-vivo study investigates early (48h), mature (2 weeks) and long-term (3 months) biofilm formation and composition on temporary push-on cones (exchangeable conical rings) made of noble-alloy-based materials (Pagalinor, PA) in comparison to Titanium-6Aluminum-7Niobium alloy (TAN) presently used in the transmucosal portion of dental implant abutments.
Detailed description
Oral biofilm (dental plaque) consists of bacteria and their metabolic products as well as saliva components and food residues. It is recognizable as a tough and structured coating on teeth and artificial surfaces within the oral cavity. Plaque development is a physiological process that begins immediately after cleaning of the oral surface. If the biofilm is not removed by daily oral hygiene, it continues to mature while changing the structure and its microbial composition.
Implant restorations comprise the osseous implant portion predominantly manufactured from titanium alloys, the transmucosal implant portion (in most implant systems as a separate abutment), and the clinical crown, which is in most systems extraorally cemented on an abutment and screw-retained onto the implant. According to current knowledge, microbial colonization of the implant abutment surface plays a significant role in the aetiology of peri-implantitis.
This study investigates the antibacterial potential of a temporary push-on cone (conical ring) that could reduce the risk of bacterial related peri-implant diseases due to decreased biofilm susceptibility, compared to current available transmucosal materials, in the short- and long-run. The test material Pagalinor®2 (PA) is an established material in dental medicine and has proven to accumulate least biofilm in an in-vivo biofilm sampling model using removable splints. The control material consists of the current transmucosal implant abutment material Titanium-6Aluminum- 7Niobium alloy (TAN). The push-on rings are designed for repeated application along the transmucosal implant abutment portion with high precision fit and will allow biofilm sampling in the natural implant environment. Profound insight into the native homeostasis of biofilm formation will be obtained and therefore enhance the knowledge about long-term tissue response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All patients enrolled in the current investigation will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner.
| Arm | Type | Receives |
|---|---|---|
| Pagalinor®2 (PA) test arm | Experimental | Device: Rings made of PA (test)All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner. |
| Titanium-6Aluminum- 7Niobium alloy (TAN) control arm | Active comparator | Device: Rings made of TAN (control)All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed Consent signed by the subject
- Presence of one or more bone level titanium implant prior to insertion of the final restoration
- No systemic illness
- No heavy smoking (smoking <10 cigarettes/day)
- No pregnancy
Key exclusion criteria (6 listed)
- Systemic illness (e.g. Diabetes)
- Heavy smoking (smoking >10 cigarettes/day)
- Known or suspected non-compliance, drug or alcohol abuse
- Pregnancy
- Active periodontitis (probing pocket depth >4 mm)
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 |
|---|---|---|
| Rings made of PA (test)Rings made of PA (test) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Test rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period). | Device | Pagalinor®2 (PA) test arm |
| Rings made of TAN (control)Rings made of TAN (control) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Control rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period). | Device | Titanium-6Aluminum- 7Niobium alloy (TAN) control arm |
Primary outcome
Change in total bacterial load formed on the removable rings of each material
Time frame: at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placement
Quantification of the bacterial load formed on the removable rings of each material by quantitative real-time PCR (qPCR) using primers specific to highly conserved regions of bacterial 16S rRNA genes.
5 secondary outcomes
Change in bacterial composition (taxonomic diversity) between different materials at various time points by using metagenomic sequencing analysis
Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in probing pocket depth (PPD) in mm
Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in bleeding on probing (BoP)
Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in noninvasive laser doppler flowmetry
Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Change in the cells of the peri-implant soft tissue
Time frame: at 2 weeks after ring placement
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 11 Aug 2026.
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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.
Nicola U. Zitzmann, Prof. Dr. principal investigator
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 Rings made of PA (test) in people with Dental Plaque and Oral Biofilm, run by University Hospital, Basel, Switzerland 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. 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?
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?
Contact Nicola U. Zitzmann, Prof. Dr. (+41 61 267 26 36, n.zitzmann@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total bacterial load formed on the removable rings of each material (time frame: at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placement). 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 11 Aug 2026.