Activity of Mouthwashes Againgst Entamoeba Spp.

NCT ID: NCT07210814

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

regular participants

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

Group Type: EXPERIMENTAL

saliva and plaque sample collection for analysis

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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 minutes, ensuring it moves around to facilitate optimal saliva collection while avoiding chewing.

Intervention Type: PROCEDURE

using commercial mouthwash

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Martina Koehsler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martina Koehsler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Institute for Specific Prophylaxis and Tropical Medicine

Vienna, , Austria

Countries

Austria

Central Contacts

Martina Koehsler, Prof. Dr.

Role: CONTACT

martina.koehsler@meduniwien.ac.at

00431401603 ext. 8243

Gabriella Dvorak, Prof. DDr.

Role: CONTACT

gabriella.dvorak@meduniwien.ac.at

0043140070 ext. 4144

Facility Contacts

Martina Koehsler, Prof. Dr.

Role: primary

martina.koehsler@meduniwien.ac.at

0043140160 ext. 38243

Julia Walochnik, Prof. Dr.

Role: backup

julia.walochnik@meduniwien.ac.at

0043140160 ext. 39446

References

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.

Reference Type: BACKGROUND

PMID: 24983705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26899578 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37317068 (View on PubMed)

Other Identifiers

1368/2025

Identifier Type: -

Identifier Source: org_study_id