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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OROXID® forte | Experimental | Medical device: OROXID® forte oral solution |
|
| Standard of care | Other | Oral solutions are not allowed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Completely Healed Wounds | Proportion of completely healed wounds at 14 days in the active versus control group. | 14 days |
| Mean Early Healing Index | Mean Early Healing Index (EHI) scores will be used to compare the groups. The EHI evaluates key clinical indicators of wound healing, including redness, swelling, bleeding, and epithelialization. Scores range from 0 to 5, with 0 representing very poor healing and 5 indicating excellent healing. Higher EHI scores correspond to more favorable healing outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Tadej Dovšak, PhD | Krizaj d.o.o. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Križaj | Recruiting | Muljava | Municipality of Ivančna Gorica | 1295 | Slovenia |
As a company operating under the jurisdiction of the EU, the organization is subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. Individual Participant Data (IPD) from clinical trials is considered sensitive personal data under GDPR.
Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, the sharing of IPD is not permitted.
For this reason, and to ensure full compliance with EU data protection regulations while safeguarding the privacy and rights of study participants, individual-level data cannot currently be shared.
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
|
| 7 and 14 days |
| Plaque Index | Differences in Plaque Index (PI) scores between the active and control groups will be evaluated using the Silness and Löe Plaque Index. This index assesses the thickness of dental plaque along the gingival margin based on the following scoring criteria: Score 0 = No plaque score; 1 = Mild plaque along the gingival margin; Score 2 =Moderate layer of plaque along gingival margin, interdental spaces free; Score 3 = Abundant plaque along the gingival margin, interdental spaces filled with plaque. Higher scores indicate poorer oral hygiene and greater plaque accumulation. | 7 and 14 days |
| Pain Relief | Assessment of additional analgesic use (measured in days) will be conducted to compare the active and control groups. | In the first 7 days |
| Infection rate | Incidence of post-operative infections in each group | 7 and 14 days |