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Not Yet RecruitingNCT07210814

Activity of Mouthwashes Againgst Entamoeba Spp.

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Medical University of Vienna · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREsaliva and plaque sample collection for analysisFor 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 mouthwashParticipants use the commercial mouthwash octenident (cosmetic) twice daily after their normal dental routine for 30 seconds for consecutive seven days

Timeline

Start date
2025-10-01
Primary completion
2026-02-01
Completion
2026-03-01
First posted
2025-10-07
Last updated
2025-10-07

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT07210814. Inclusion in this directory is not an endorsement.