Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06987253

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

Led by ENIKAM d.o.o. · Updated on 2025-12-01

60

Participants Needed

1

Research Sites

29 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Klinika Križaj

Muljava, Municipality of Ivančna Gorica, Slovenia, 1295

Actively Recruiting

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Research Team

D

Dominika Tompa Majcen MPharm

CONTACT

D

Dominika Tompa Majcen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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