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NCT Number: NCT05122897

Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZB (University Center for Dental Medicine Basel)

Basel, 4058, Switzerland

Location status: Recruiting

Location contact

Lucia K. Zaugg, Dr. med. dent.

CONTACT

[email protected]

+41 61 267 26 36

Lucia K. Zaugg, Dr. med. dent.

PRINCIPAL_INVESTIGATOR

Nicola U. Zitzmann, Prof. Dr.

CONTACT

[email protected]

+41 61 267 26 36

Nicola U. Zitzmann, Prof. Dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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%.

  2. 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 probing pocket depth (PPD) to investigate the inflammatory tissue response

  3. Change in bleeding on probing (BoP)

    Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement

    Recording bleeding on probing (BoP) to investigate the inflammatory tissue response

  4. Change in noninvasive laser doppler flowmetry

    Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement

    Change in noninvasive laser doppler flowmetry to to measure the blood flow of mucosa next to the ring

  5. Change in the cells of the peri-implant soft tissue

    Time frame: at 2 weeks after ring placement

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia K. Zaugg, Dr. med. dent.

CONTACT

[email protected]

+41 61 267 26 36

Nicola U. Zitzmann, Prof. Dr.

CONTACT

[email protected]

+41 61 267 26 36

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • ITI International Team for Implantology, Switzerland

Registry information

Official study title

Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2021
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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