Parasite Infestation
Conditions
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
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.
Participants use the commercial mouthwash octenident (cosmetic) twice daily after their normal dental routine for 30 seconds for consecutive seven days
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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