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

Primary Purpose

Dental Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Intraoral apparatus
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Diseases focused on measuring intraoral biofilm formation, parodontitis, tooth implant, periimplant diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University Center for Dentistry Basel UZB

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoral apparatus

Arm 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

number of CFU
Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter.

Full Information

First Posted
November 30, 2020
Last Updated
December 1, 2020
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04657757
Brief Title
Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Official Title
Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
Keywords
intraoral biofilm formation, parodontitis, tooth implant, periimplant diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
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.
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraoral apparatus
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Intraoral apparatus
Intervention Description
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).
Primary Outcome Measure Information:
Title
quantification of biofilm
Description
quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).
Time Frame
2x 24hours in a period of about 10 days
Secondary Outcome Measure Information:
Title
number of CFU
Description
Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter.
Time Frame
2x 24hours in a period of about 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Zitzmann, MD PhD
Organizational Affiliation
University Center for Dentistry Basel UZB
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center for Dentistry Basel UZB
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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