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

Dental Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657757
• Other study ID #: 2018-00248; sp20Zeller
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases

Intervention

Other:
• Intraoral 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).

Locations

Country	Name	City	State
Switzerland	University Center for Dentistry Basel UZB	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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