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

Study Overview
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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.

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

Conditions
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Dental Diseases

Intervention / Treatment
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* Other: Intraoral apparatus


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoral apparatus<br>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. | Other: Intraoral apparatus<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2x 24hours in a period of about 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of CFU | Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter. | 2x 24hours in a period of about 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoral biofilm formation, parodontitis, tooth implant, periimplant diseases