Activity of Mouthwashes Againgst Entamoeba Spp.

Medical University of Vienna

Status: Not yet enrolling

Conditions: Parasite Infestation

Treatments: Other: using commercial mouthwash; Procedure: saliva and plaque sample collection for analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07210814

1368/2025

Details and patient eligibility

About

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®.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

regular participants

Experimental group

Description:

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

Treatment:

Procedure: saliva and plaque sample collection for analysis

Other: using commercial mouthwash