Activity of Mouthwashes Againgst Entamoeba Spp.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: saliva and plaque sample collection for analysis, using commercial mouthwash.
- Who it may be relevant to
- Registry conditions: Parasite Infestation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study on the Activity of Commercially Available Mouthwashes Againgst Entamoeba Spp.
Overview
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®.
Interventions
- Procedure saliva and plaque sample collection for analysis
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 minut - Other using commercial mouthwash
Participants use the commercial mouthwash octenident (cosmetic) twice daily after their normal dental routine for 30 seconds for consecutive seven days
Primary outcome measures
- Change in E. gingivalis DNA quantity after using the mouthwash octenident®. [Time frame: 8 days, pre-treatment (day one, first sampling), 7 days using mouthwash, final sampling (day 8)]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years or older
- Able and willing to provide written informed consent
- Positive identification of Entamoeba gingivalis in oral samples collected during screening, confirmed by specific PCR
Exclusion criteria
- Antibiotic therapy or periodontal treatment within the last 6 months
- Current orthodontic treatment
- Underlying systemic diseases (e.g., diabetes mellitus)
- Autoimmune diseases
- Acute infections and other conditions requiring medication
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Austria · 1 center
- Institute for Specific Prophylaxis and Tropical Medicine — Vienna
Publications
- Bonner M, Amard V, Bar-Pinatel C, Charpentier F, Chatard JM, Desmuyck Y, Ihler S, Rochet JP, Roux de La Tribouille V, Saladin L, Verdy M, Girones N, Fresno M, Santi-Rocca J. Detection of the amoeba Entamoeba gingivalis in periodontal pockets. Parasite. 2014;21:30. doi: 10.1051/parasite/2014029. Epub 2014 Jul 2. PMID 24983705
- Kung E, Pietrzak J, Klaus C, Walochnik J. In vitro effect of octenidine dihydrochloride against Trichomonas vaginalis. Int J Antimicrob Agents. 2016 Mar;47(3):232-4. doi: 10.1016/j.ijantimicag.2015.12.010. Epub 2016 Jan 21. PMID 26899578
- Kohsler M, Kniha E, Wagner A, Walochnik J. Pilot Study on the Prevalence of Entamoeba gingivalis in Austria-Detection of a New Genetic Variant. Microorganisms. 2023 Apr 22;11(5):1094. doi: 10.3390/microorganisms11051094. PMID 37317068
Identifiers
NCT: NCT07210814 · 1368/2025