Influence of Different Zirconia Surface Treatments on Biofilm Formation

Surface Finish Clinical Trial

— Biofilm2020  

Official title:

Influence of Different Zirconia Surface Treatments on Biofilm Formation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181099
• Other study ID #: 2019-01918
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2021
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surface Finish

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Center for Dental Medicine Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safranin Staining	The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer	3 months
Secondary	SEM	The morphology of the biofilm is analyzed using scanning electron microscopy	3 months