Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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