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

NCT06987253 | Recruiting

• 1 other identifier: OROXID-PR-01-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Oral cavity wound; Hydrogen peroxide; Mouthwash

Outcome Measures

Primary Outcomes (1)

• Modified Landry Index

  Differences in the total score of the individual components of the Modified Landry Index between the active and control groups. This entails evaluating the following parameters in a comparative manner using a dichotomic score: gingival color (0 = red, 1 = pink); granulation tissue (0 = present, 1 = absent); tissue epithelialization (0 = partial/1 = complete); swelling (0 = pres- ence, 1 = absent); bleeding on palpation (0 = present, 1 = absent); sup- puration on palpation (0 = present, 1 = absent). The total score, ranging from 0 to 6, reflects the overall quality of healing, with higher scores indicating more favorable outcomes.

  7 days

Secondary Outcomes (5)

• Completely Healed Wounds

  14 days

• Mean Early Healing Index

  7 and 14 days

• Plaque Index

  7 and 14 days

• Pain Relief

  In the first 7 days

• Infection rate

  7 and 14 days

Study Arms (2)

OROXID® forte

EXPERIMENTAL

Medical device: OROXID® forte oral solution

Device: OROXID® forte oral solution

Standard of care

OTHER

Oral solutions are not allowed

Other: Standard of Care (SOC)

Interventions

OROXID® forte oral solution DEVICE

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

OROXID® forte

Standard of Care (SOC) 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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ENIKAM d.o.o.: lead

Study Sites (1)

Klinika Križaj

Muljava, Občina Ivančna Gorica, 1295, Slovenia

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tadej Dovšak, PhD

  Krizaj d.o.o.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominika Tompa Majcen MPharm

CONTACT

+386 40 530 663; dominika@enikam-oxy.com

Dominika Tompa Majcen

CONTACT

+386 40 530 663; dominika@enikam-oxy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 23, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)