An interventional study of saliva and plaque sample collection for analysis and using commercial mouthwash in Parasite Infestation, sponsored by Medical University of Vienna. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Prevention
The amoeba Entamoeba gingivalis colonizes the human oral cavity, where it can actively destroy tissue and cause local inflammation. Currently, there is no standard treatment for E. gingivalis infection. Even during treatment for periodontitis, there is no specific treatment targeting E. gingivalis, although this could significantly improve the effectiveness and long-term results of periodontitis therapy. Octenidine is an antiseptic agent used for disinfecting skin, mucous membranes, and wounds. It is effective against bacteria, fungi, and some viruses. octenident® is a commercially available cosmetic mouthwash containing octenidine as the active ingredient. Its efficacy against Entamoeba spp. will be tested in vitro. Because E. gingivalis is very difficult to cultivate under laboratory conditions, and in vitro testing may not be feasible, the effect of using the mouthwash octenident® (cosmetic product) twice daily for 30 seconds over a 7-day period on the quantity of E. gingivalis will be evaluated in healthy volunteers using quantitative real-time PCR, a technique enabling the comparison of E. gingivalis DNA before and after the use of octenident®.
55 studies on the registry are indexed under Parasitic Diseases; 8 are open to participants now.
This study's planned enrollment of 40 is below the median of 151 across 41 interventional studies indexed under Parasitic Diseases.
Browse Parasitic Diseases studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
inital sampling, plaque and saliva is collected by a medical professional, for 7 days a mouthwash is used twice dayly for 30 seconds, final sampling, plaque and saliva is collected by a medical professional
Procedure: saliva and plaque sample collection for analysis · Other: using commercial mouthwash
For collection of plaque two different gingival sites are selected for sampling in each participant. Prior to sampling, supragingival plaque is removed with a sterile instrument. Subgingival plaque is then collected from the same site using a sterile Gracey curette. Saliva samples are collected using a commercially available saliva collection kit (Sallivete®, SARSTEDT AG, Germany). Participants should open the Sallivete® tube, remove the synthetic swab, and place it in their mouth for 1-2 minutes, ensuring it moves around to facilitate optimal saliva collection while avoiding chewing.
Participants use the commercial mouthwash octenident (cosmetic) twice daily after their normal dental routine for 30 seconds for consecutive seven days
Change in E. gingivalis DNA quantity after using the mouthwash octenident®.
Quantification of E. gingivalis DNA levels using quantitative polymerase chain reaction (qPCR) before (day 1) and after (day 8) using the mouthwash octenident® twice daily for seven days. Total DNA will be isolated from plaque and saliva samples on day 1 and day 8. The outcome will be reported as the absolute change in E. gingivalis DNA concentration from baseline to post-treatment. A standard curve will be generated using a dilution series of DNA with known concentrations. DNA concentrations in study samples will be interpolated from this curve to assess absolute changes in DNA quantity before and after treatment.
Time frame: 8 days, pre-treatment (day one, first sampling), 7 days using mouthwash, final sampling (day 8)
Plan to share: No — not relevant for this study
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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