Biofilm2020: Influence of Different Zirconia Surface Treatments on Biofilm Formation

• Sponsor: University of Basel (Other)
• Overall Status: Completed
• CT.gov ID: NCT04181099
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surface Finish	Other: Implant neck surface	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Influence of Different Zirconia Surface Treatments on Biofilm Formation
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. SEM [3 months]

   The morphology of the biofilm is analyzed using scanning electron microscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Center for Dental Medicine Basel	Basel	Basel-Stadt	Switzerland	4058

Sponsors and Collaborators

• University of Basel

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nadja Rohr, Principal Investigator, University of Basel
• ClinicalTrials.gov Identifier: NCT04181099
• Other Study ID Numbers: 2019-01918
• First Posted: Nov 29, 2019
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nadja Rohr, Principal Investigator, University of Basel: dental implant; zirconia; biofilm

Study Results

No Results Posted as of Apr 28, 2021