Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07270705

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

Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Gingivitis can be managed with regular and proper tooth brushing and the use of interdental brushes. In cases of more extensive inflammation affecting multiple or all teeth, dental treatment may be required, including scaling, air polishing, or both. Depending on the dentist's assessment, inflamed gums may also be treated with antibiotic therapy.

As an adjunctive therapy to manage inflamed gums and maintain proper oral hygiene, the use of mouth rinses or oral solutions containing chlorhexidine, hyaluronic acid, chitosan, or active oxygen (peroxide) is recommended. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult.

One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinika Križaj Ljubljana, Ljubljana, Slovenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systemically healthy participants aged 18 years or older.
  • Presence of at least 20 natural teeth.
  • Probing pocket depth less than or equal to 3 mm.
  • Presence of bleeding on probing in more than 10% of sites.
  • Mean Gingival Index (Silness & Löe) of at least 1.
  • Ability and willingness to follow oral hygiene instructions after the intervention.
  • Signed informed consent form after being informed about the study.

Exclusion criteria

  • Periodontal treatment within the last three months.
  • Diagnosis of periodontitis.
  • Use of mouth rinses or oral gels within the last month.
  • Use of antibiotic therapy within the last three months.
  • Known allergy or hypersensitivity to any components of the investigational products.
  • Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications.
  • Presence of systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic kidney disease, tuberculosis, or autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease).
  • Use of immunosuppressive medications.
  • Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture.
  • Pregnant or breastfeeding women.
  • Smokers.

Treatment and study plan

OROXID® forte oral solution

Device

Patients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care.

OROXID® sensitive oral solution

Device

Patients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care.

Standard of care

Other

Patients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load.

Primary outcomes

  1. Gingival Index (GI) at Day 7

    Time frame: Baseline and Day 7

    Mean change in Gingival Index (Silness and Löe) scores from baseline to day 7, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing.

  2. Plaque Index (PI) at Day 7

    Time frame: Baseline and Day 7

    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.

  3. Bleeding on Probing (BOP) at Day 7

    Time frame: Baseline and Day 7

    Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 7 days of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.

Secondary outcomes

  1. Gingival Index (GI) at Day 14 and 28

    Time frame: Baseline, Day 14, and Day 28

    Mean change in Gingival Index (Silness and Löe) scores from baseline to day 14, and 28, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing.

  2. Plaque Index (PI) at Day 14 and 28

    Time frame: Baseline, Day 14, and Day 28

    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.

  3. Bleeding on Probing (BOP) at Day 14 and 28

    Time frame: Baseline, Day 14, and Day 28

    Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 14 and 28 days of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.

  4. Rate of infection

    Time frame: Baseline to Day 28

    Incidence of infections in each group

  5. Adverse events

    Time frame: Baseline to Day 28

    Number and percentage of participants experiencing adverse events (AEs) related to the use of OROXID® forte or OROXID® sensitive during the 12-week study period. The nature, severity, and relationship of each AE to the study product will be recorded and analyzed.

Study contacts

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

Dominika Tompa Majcen, MPharm

CONTACT

[email protected]

+386 40 530 663

Sponsors and collaborators

Lead sponsor

ENIKAM d.o.o.

Industry

Registry information

Acronym: OroxGing

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 8, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.