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Completed

NCT Number: NCT04181099

Influence of Different Zirconia Surface Treatments on Biofilm Formation

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.

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Key information

Conditions

Surface Finish

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center for Dental Medicine Basel

Basel, Canton of Basel-City, 4058, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Implant neck surface

Other

The biofilm formation is tested on discs manufactured of zirconia with different surfaces in vivo using orthodontic devices that the participants carry over 24h

Primary outcomes

  1. 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

Secondary outcomes

  1. SEM

    Time frame: 3 months

    The morphology of the biofilm is analyzed using scanning electron microscopy

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Registry information

Acronym: Biofilm2020

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Apr 28, 2021

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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