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

NCT04657757 | Completed

• 1 other identifier: 2018-00248; sp20Zeller
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Diseases

Keywords

intraoral biofilm formation; parodontitis; tooth implant; periimplant diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of CFU

  2x 24hours in a period of about 10 days

Study Arms (1)

Intraoral apparatus

EXPERIMENTAL

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

Interventions

Intraoral apparatus OTHER

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).

Intraoral apparatus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Center for Dentistry Basel UZB

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Stomatognathic Diseases; Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases

Study Officials

• Nicola Zitzmann, MD PhD

  University Center for Dentistry Basel UZB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 8, 2020
• Study Start: March 14, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)