Viewing Study NCT04657757


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Study NCT ID: NCT04657757
Status: COMPLETED
Last Update Posted: 2020-12-08
First Post: 2020-11-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Sponsor: University Hospital, Basel, Switzerland
Organization:

Study Overview

Official Title: Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Status: COMPLETED
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: