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

University Hospital, Basel, Switzerland16 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dental Diseases

Interventions

Intraoral apparatusOTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Center for Dentistry Basel UZB

Basel, Switzerland

Outcomes

Primary Outcomes

quantification of biofilm

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

Time frame: 2x 24hours in a period of about 10 days

Secondary Outcomes

number of CFU

Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter.

Time frame: 2x 24hours in a period of about 10 days

Data from ClinicalTrials.gov

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