Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
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| ClinicalTrials.gov Identifier: NCT04657757 |
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Recruitment Status :
Completed
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dental Diseases | Other: Intraoral apparatus | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | N/A |
| Intervention 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. |
| Primary Purpose: | Prevention |
| Official Title: | Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials |
| Actual Study Start Date : | March 14, 2018 |
| Actual Primary Completion Date : | March 31, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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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). |
- quantification of biofilm [ Time Frame: 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).
- number of CFU [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657757
| Switzerland | |
| University Center for Dentistry Basel UZB | |
| Basel, Switzerland, 4031 | |
| Principal Investigator: | Nicola Zitzmann, MD PhD | University Center for Dentistry Basel UZB |
| Responsible Party: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT04657757 |
| Other Study ID Numbers: |
2018-00248; sp20Zeller |
| First Posted: | December 8, 2020 Key Record Dates |
| Last Update Posted: | December 8, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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intraoral biofilm formation parodontitis tooth implant periimplant diseases |
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Stomatognathic Diseases |