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

ENIKAM d.o.o.

Status: Enrolling

Conditions: Wound Healing; Tooth Extrusion

Treatments: Other: Standard of Care (SOC); Device: OROXID® forte oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06987253

OROXID-PR-01-25

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Systemically healthy individuals aged 18 years or older.
2. Indicated for surgical removal of an erupted or unerupted tooth and/or apicoectomy.
3. Ability and willingness to comply with post-operative oral hygiene instructions.
4. Signed informed consent form prior to participation in the study.

Exclusion criteria

1. Receipt of periodontal treatment within the past 3 months.
2. Use of mouthwashes or oral gels in the past month.
3. Presence of active gingivitis around the tooth scheduled for extraction.
4. Known allergy to any ingredients of the investigational products.
5. Presence of inflammatory conditions in the oral cavity, such as lichen planus, bullous lesions, or active gingivitis.
6. Immunocompromised individuals.
7. Known allergy to penicillin or diclofenac.
8. Pregnant or breastfeeding women.
9. Smokers who consume more than 15 cigarettes per day.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

OROXID® forte

Experimental group

Description:

Medical device: OROXID® forte oral solution

Treatment:

Device: OROXID® forte oral solution

Standard of care

Other group

Description:

Oral solutions are not allowed

Treatment:

Other: Standard of Care (SOC)