Dental Diseases
Conditions
Keywords
intraoral biofilm formation, parodontitis, tooth implant, periimplant diseases
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.
Interventions
OTHERIntraoral 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).
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quantification of biofilm | 2x 24hours in a period of about 10 days | quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of CFU | 2x 24hours in a period of about 10 days | Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter. |
Countries
Switzerland
Outcome results
None listed