Influence of Different Zirconia Surface Treatments on Biofilm Formation (Biofilm2020)

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.

Study Overview

• Status: Completed
• Conditions: Surface Finish
• Intervention / Treatment: Other: Implant neck surface

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4058
      • University Center for Dental Medicine Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Zirconia structure; The participants will carry an orthodontic device containing 4 discs of differently structured zirconia and titanium to test the biofilm formation in order to determine the ideal structure for the neck area of zirconia dental implants.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SEM	The morphology of the biofilm is analyzed using scanning electron microscopy	3 months

Collaborators and Investigators

• Sponsor: University of Basel
• Investigators: Study Director: Jens Fischer, Prof, University Center for Dental Medicine Basel

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (ACTUAL): November 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: dental implant; biofilm; zirconia
• Other Study ID Numbers: 2019-01918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No