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Activity of Mouthwashes Againgst Entamoeba Spp.

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07210814
Enrollment
40
Registered
2025-10-07
Start date
2025-10-01
Completion date
2026-03-01
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parasite Infestation

Keywords

Entamoeba gingivalis, mouthwash

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®.

Interventions

PROCEDUREsaliva 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.

OTHERusing commercial mouthwash

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

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in E. gingivalis DNA quantity after using the mouthwash octenident®.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.

Countries

Austria

Contacts

Primary ContactMartina Koehsler, Prof. Dr.
martina.koehsler@meduniwien.ac.at00431401603
Backup ContactGabriella Dvorak, Prof. DDr.
gabriella.dvorak@meduniwien.ac.at0043140070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026