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

University Hospital Basel

Status: Completed

Conditions: Dental Diseases

Treatments: Other: Intraoral apparatus

Study type: Interventional

Funder types: Other

Identifiers

NCT04657757

2018-00248 sp20Zeller;

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Intraoral apparatus

Experimental group

Description:

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.

Treatment:

Other: Intraoral apparatus