Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05122897

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

Led by University Hospital, Basel, Switzerland · Updated on 2025-07-25

33

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Basel, Switzerland

Lead Sponsor

I

ITI International Team for Implantology, Switzerland

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to study how biofilms form and change over time on temporary push-on rings made from different materials used in dental implant abutments. The study compares a noble-alloy-based material called Pagalinor (PA) to the commonly used Titanium-6Aluminum-7Niobium alloy (TAN) in patients with titanium bone level implants. Understanding biofilm formation on these materials may help reduce bacterial-related peri-implant diseases like peri-implantitis. Participants will wear temporary push-on rings made from either the PA test material or the TAN control material, which are placed on the conical titanium base of their implant crowns. The rings, 0.2mm thick, will be replaced after 48 hours, 2 weeks, and 3 months to measure bacterial biofilm. In patients with two implants, the rings will be applied simultaneously in a split-mouth design; in patients with one implant, the rings will be used consecutively. The study duration is 4 months for split-mouth and 8 months for single implant participants. Throughout the study, researchers will collect and analyze biofilm samples from the rings to measure total bacterial load and changes in bacterial composition over time. They will also assess clinical measures such as probing pocket depth, bleeding on probing, laser doppler flowmetry, and peri-implant soft tissue cells at specified time points. These assessments will provide insight into biofilm development and tissue response with each material over the short and long term.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Presence of one or more bone level titanium implant before final restoration
  • No systemic illness
  • Smoking less than 10 cigarettes per day
  • Not pregnant
  • No active periodontitis with probing pocket depth 4 mm or less
  • No pharmacological or antibiotic treatment during or up to three months before the study
Not Eligible

You will not qualify if you...

  • Systemic illness such as diabetes
  • Smoking more than 10 cigarettes per day
  • Known or suspected non-compliance, drug or alcohol abuse
  • Pregnancy
  • Active periodontitis with probing pocket depth greater than 4 mm
  • Pharmacological or antibiotic treatment during or up to three months before the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 4 to 8 months depending on number of implants

Participants will have temporary push-on rings made of PA (test) and TAN (control) materials placed on their implant crowns. These rings are removed and replaced after 48 hours, 2 weeks, and 3 months for biofilm sampling and bacterial analysis.

3 visits for ring removal and replacement

Trial Site Locations

Total: 1 location

1

UZB (University Center for Dental Medicine Basel)

Basel, Switzerland, 4058

Actively Recruiting

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Research Team

N

Nicola U. Zitzmann, Prof. Dr.

L

Lucia K. Zaugg, Dr. med. dent.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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