Clinical Trial

Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery

Study acronym: OroxSurge
Recruiting
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Record status
This record was last updated December 1, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Oral tissue healing is significantly affected by the high bacterial load and constant mechanical stress within the oral cavity. To control bacterial colonization and support healing, both topical and systemic treatments-such as antibiotics and anti-inflammatory agents-are commonly recommended. In addition to pharmacological therapies, mouthwashes containing peroxide, hyaluronic acid, chitosan, or chlorhexidine are often used to maintain low levels of pathogenic bacteria. However, current recommendations for mouthwash use are primarily based on their antibacterial properties in a healthy oral environment. Evidence supporting their role in promoting wound healing, particularly after oral surgery, remains limited. OROXID® mouthwash is a medical device formulated with active oxygen (peroxide compounds). It supports the prevention and relief of inflammation in gingival and paranasal tissues through mechanical action: the release of oxygen bubbles helps cleanse tissues by removing debris. OROXID® acts locally on the mucosal microenvironment by moistening, oxygenating, and clearing away particles and dead cells. Additionally, its slightly acidic pH (between 3 and 5) helps inhibit microbial growth. The investigators hypothesize that OROXID® may reduce post-operative side effects and complications following wisdom tooth extraction and contribute to faster wound healing.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-15; most recent amendment 2025-11-26.
Status change: Not Yet Recruiting → Recruiting 2025-11-26
Trial Details
NCT Number NCT06987253
Lead Sponsor ENIKAM d.o.o.
Conditions Tooth Extrusion, Wound Healing
Enrollment 60 participants
Start Date 2025-11-06
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-01