Influence of Different Zirconia Surface Treatments on Biofilm Formation

NCT ID: NCT04181099

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-08-01

Brief Summary

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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

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Conditions

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Surface Finish

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Implant neck surface

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Nadja Rohr

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Fischer, Prof

Role: STUDY_DIRECTOR

University Center for Dental Medicine Basel

Locations

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University Center for Dental Medicine Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-01918

Identifier Type: -

Identifier Source: org_study_id

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