Clinical trial NCT06987253: Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
Official title: Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Extrusion
Wound Healing
Keywords: Oral cavity wound
Hydrogen peroxide
Mouthwash
Lead sponsor: ENIKAM d.o.o.
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Modified Landry Index
timeFrame: 7 days
Secondary outcomes:
measure: Completely Healed Wounds
timeFrame: 14 days
measure: Mean Early Healing Index
timeFrame: 7 and 14 days
measure: Plaque Index
timeFrame: 7 and 14 days
measure: Pain Relief
timeFrame: In the first 7 days
measure: Infection rate
timeFrame: 7 and 14 days
Other outcomes:
Locations:
city: Muljava
country: Slovenia
facility: Klinika Križaj
state: Ivančna Gorica
Study officials:
affiliation: Krizaj d.o.o.
name: Tadej Dovšak, PhD
role: PRINCIPAL_INVESTIGATOR
References: