Influence of Different Zirconia Surface Treatments on Biofilm Formation

Not Applicable

Completed

• Conditions: Surface Finish
• Interventions: Other: Implant neck surface

• Registration Number: NCT04181099
• Lead Sponsor: University of Basel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Study Start: 2020-01-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-08-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zirconia structure	Implant neck surface	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.

Primary Outcome Measures

Name	Time	Method
Safranin Staining	3 months	The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer

Secondary Outcome Measures

Name	Time	Method
SEM	3 months	The morphology of the biofilm is analyzed using scanning electron microscopy

Trial Locations

Locations (1)

University Center for Dental Medicine Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland