Clinical Trials Directory

Trials / Completed

CompletedNCT04657757

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERIntraoral apparatusEight 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).

Timeline

Start date
2018-03-14
Primary completion
2020-03-31
Completion
2020-03-31
First posted
2020-12-08
Last updated
2020-12-08

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04657757. Inclusion in this directory is not an endorsement.