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Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials

NCT ID: NCT04657757

Last Updated: 2020-12-08

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

2018-03-14

Study Completion Date

2020-03-31

Brief Summary

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Investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials

Detailed Description

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The aim of this study is to investigate bacterial attachment and bactericidal effects of different materials used for the transmucosal part of implants. Using a brace, the intraoral biofilm formation in healthy subjects will be measured after 28 hours (24 hours intraorally, 4 hours rest). For this purpose 2 sterile platelets of each of the 8 differently processed materials (16 platelets in total) are inserted into the braces.

The main target parameter is the quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).

As secondary target parameter possible bactericidal effects of the materials, which are analyzed by Colony forming units (CFU) determination, are used.

Conditions

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Dental Diseases

Keywords

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intraoral biofilm formation parodontitis tooth implant periimplant diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The test persons are numbered so that the laboratory technician who performs the analysis of the platelets cannot be assigned a name. Blinding with regard to the materials is not possible, as the color differences of the alloys allow for a classification.

Study Groups

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Intraoral apparatus

intraoral apparatus in which two platelets of each of the 8 materials (Esteticor Lumina PF; Esteticor Lumina PF - after Lactic acid storage; Pagalinor 2; Esteticor Economic; Pekkton ivory - untreated; Pekkton ivory - rough; Oralloy; Machined Titan Zirconia (TiZr) alloy) are to be examined. Examination is a crystal violet OD595 staining (10 minutes). The color absorbed by the bacteria is then dissolved with a 30% acetic acid and measured spectrophotometrically at 595 nm. The plaque formed on the material surface is removed immediately after removal from the oral cavity and analyzed by determination of Colony Forming Unit (CFU) number.

Group Type EXPERIMENTAL

Intraoral apparatus

Intervention Type OTHER

Eight platelets with different material composition and surface properties are fastened in a holder (carrier rondell) with 15 mm diameter and inserted into the braces. Braces are to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures. Platelets then are removed and analyzed. After a first course the braces are to be cleaned in chlorhexidine solution in an ultrasonic bath; followed by a second identical course (Braces to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures).

Interventions

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Intraoral apparatus

Eight platelets with different material composition and surface properties are fastened in a holder (carrier rondell) with 15 mm diameter and inserted into the braces. Braces are to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures. Platelets then are removed and analyzed. After a first course the braces are to be cleaned in chlorhexidine solution in an ultrasonic bath; followed by a second identical course (Braces to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No systemic antibiotic therapy during the last 3 months
* Good oral hygiene and compliance (plaque index (PI) \<20%, bleeding index (BI) \<20%)
* No signs of periodontitis or other inflammatory changes in surrounding tissues
* Non-smokers

Exclusion Criteria

* Disease that requires antibiotics
* Pressure points caused by the braces, which cannot be eliminated by adjusting
* Other unforeseen complications that can be associated with braces
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicola Zitzmann, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Center for Dentistry Basel UZB

Locations

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University Center for Dentistry Basel UZB

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-00248; sp20Zeller

Identifier Type: -

Identifier Source: org_study_id