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

NCT ID: NCT06987253

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Tooth Extrusion; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OROXID® forte

Medical device: OROXID® forte oral solution

Group Type: EXPERIMENTAL

OROXID® forte oral solution

Intervention Type: DEVICE

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

Standard of care

Oral solutions are not allowed

Group Type: OTHER

Standard of Care (SOC)

Intervention Type: OTHER

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.

Interventions

OROXID® forte oral solution

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

Intervention Type: DEVICE

Standard 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ENIKAM d.o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tadej Dovšak, PhD

Role: PRINCIPAL_INVESTIGATOR

Krizaj d.o.o.

Locations

Klinika Križaj

Muljava, Občina Ivančna Gorica, Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Dominika Tompa Majcen MPharm

Role: CONTACT

dominika@enikam-oxy.com

+386 40 530 663

Dominika Tompa Majcen

Role: CONTACT

dominika@enikam-oxy.com

+386 40 530 663

Facility Contacts

Tadej Dovšak Doctor of Medicine, Doctor of Dental Medicine, PhD

Role: primary

info@klinikakrizaj.si

0038651300415

Other Identifiers

OROXID-PR-01-25

Identifier Type: -

Identifier Source: org_study_id