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

Not Applicable

Completed

• Conditions: Dental Diseases
• Interventions: Other: Intraoral apparatus

• Registration Number: NCT04657757
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2018-03-14
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoral apparatus	Intraoral apparatus	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Center for Dentistry Basel UZB; 🇨🇭 Basel, Switzerland