RecruitingNot ApplicableNCT06987253

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


Sponsor

ENIKAM d.o.o.

Enrollment

60 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an oral rinse solution called OROXID helps with healing and prevents complications (such as dry socket or infection) after dental surgery, specifically tooth extraction or a root tip removal procedure (apicoectomy). **You may be eligible if...** - You are 18 or older and generally healthy - You are scheduled to have a tooth extracted or have an apicoectomy (removal of the root tip) - You are willing and able to follow post-operative oral hygiene instructions **You may NOT be eligible if...** - You have had periodontal (gum) treatment in the past 3 months - You have used a mouthwash or oral gel in the past month - You have active gum disease around the tooth being extracted - You have an allergy to any ingredient in the study products (including penicillin) - You have inflammatory mouth conditions such as lichen planus or active gingivitis - You have a weakened immune system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOROXID® forte oral solution

Patients will use OROXID® forte oral solution two to three times daily for 14 days as an adjunct to standard care.

OTHERStandard of Care (SOC)

Patients will receive standard of care meaning proper tooth brushing without the use of any mouthwash or other products aimed at reducing bacteria in the oral cavity.


Locations(1)

Klinika Križaj

Muljava, Municipality of Ivančna Gorica, Slovenia

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NCT06987253


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