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NCT Number: NCT07210814

Activity of Mouthwashes Againgst Entamoeba Spp.

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®.

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Key information

Conditions

Parasite Infestation Infections Parasitic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

Location contact

Julia Walochnik, Prof. Dr.

CONTACT

[email protected]

0043140160 ext. 39446

Katharina Kranner, BA

SUB_INVESTIGATOR

Martina Koehsler, Prof. Dr.

CONTACT

[email protected]

0043140160 ext. 38243

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Dvorak, Prof. DDr.

CONTACT

[email protected]

0043140070 ext. 4144

Martina Koehsler, Prof. Dr.

CONTACT

[email protected]

00431401603 ext. 8243

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Pilot Study on the Activity of Commercially Available Mouthwashes Againgst Entamoeba Spp.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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