Activity of Mouthwashes Againgst Entamoeba Spp.

NCT07210814 | Not Yet Recruiting

• 1 other identifier: 1368/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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®.

Conditions

Parasite Infestation

Keywords

Entamoeba gingivalis; mouthwash

Outcome Measures

Primary Outcomes (1)

• 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.

  8 days, pre-treatment (day one, first sampling), 7 days using mouthwash, final sampling (day 8)

Study Arms (1)

regular participants

EXPERIMENTAL

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

Interventions

saliva and plaque sample collection for analysis PROCEDURE

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.

regular participants

using commercial mouthwash OTHER

Participants use the commercial mouthwash octenident (cosmetic) twice daily after their normal dental routine for 30 seconds for consecutive seven days

regular participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Institute for Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parasitic Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Martina Koehsler, Prof. Dr.

  Institute for Specific Prophylaxis and Tropical Medicine, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Koehsler, Prof. Dr.

CONTACT

00431401603; martina.koehsler@meduniwien.ac.at

Gabriella Dvorak, Prof. DDr.

CONTACT

0043140070; gabriella.dvorak@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)