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NCT Number: NCT06987253

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

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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Key information

Conditions

Tooth Extrusion Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinika Križaj

Muljava, Municipality of Ivančna Gorica, 1295, Slovenia

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

0038651300415

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Modified Landry Index

    Time frame: 7 days

    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.

Secondary outcomes

  1. Completely Healed Wounds

    Time frame: 14 days

    Proportion of completely healed wounds at 14 days in the active versus control group.

  2. Mean Early Healing Index

    Time frame: 7 and 14 days

    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.

  3. Plaque Index

    Time frame: 7 and 14 days

    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.

  4. Pain Relief

    Time frame: In the first 7 days

    Assessment of additional analgesic use (measured in days) will be conducted to compare the active and control groups.

  5. Infection rate

    Time frame: 7 and 14 days

    Incidence of post-operative infections in each group

Study contacts

Contact information is provided by the study sponsor or research team.

Dominika Tompa Majcen

CONTACT

[email protected]

+386 40 530 663

Dominika Tompa Majcen MPharm

CONTACT

[email protected]

+386 40 530 663

Sponsors and collaborators

Lead sponsor

ENIKAM d.o.o.

Industry

Registry information

Acronym: OroxSurge

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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