OROXID® oral solution for treating gingivitis

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

This test checks whether OROXID® oral solution (forte or sensitive) helps reduce gum inflammation and bleeding in adults with gingivitis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ENIKAM d.o.o. (industry)
• Locations: 2 sites (Ljubljana and 1 other locations)
• Trial ID: NCT07270705 on ClinicalTrials.gov

What this trial studies

Adults with gingivitis who meet entry criteria will receive one of two OROXID® oral solution formulations (forte or sensitive) or standard of care as an adjunct to routine oral hygiene. Clinical outcomes such as Gingival Index and bleeding on probing will be recorded at baseline and follow-up visits to measure changes in gum inflammation. The investigational products contain active oxygen (hydrogen peroxide) and are intended as mouth rinses or oral solutions to reduce plaque and support tissue healing. Participants must be systemically healthy and have at least 20 natural teeth to enroll.

Who should consider this trial

Good fit: Adults 18 or older who are systemically healthy, have at least 20 natural teeth, probing depths ≤3 mm, bleeding on probing in >10% of sites, and a mean Gingival Index ≥1 are ideal candidates.

Not a fit: Patients with diagnosed periodontitis, recent periodontal treatment, recent antibiotic or mouthrinse use, systemic diseases, or allergies to study product components are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, OROXID® could reduce gum inflammation and bleeding and help maintain oral hygiene as an easy-to-use adjunct to brushing.

How similar studies have performed: Peroxide-based and other active-oxygen mouth rinses have shown modest reductions in plaque and gingival inflammation in prior studies.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Periodontal treatment within the last three months.
2. Diagnosis of periodontitis.
3. Use of mouth rinses or oral gels within the last month.
4. Use of antibiotic therapy within the last three months.
5. Known allergy or hypersensitivity to any components of the investigational products.
6. Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications.
7. 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).
8. Use of immunosuppressive medications.
9. Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture.
10. Pregnant or breastfeeding women.
11. Smokers.

Where this trial is running

Ljubljana and 1 other locations

• Klinika Križaj Ljubljana — Ljubljana, Slovenia (RECRUITING)
• Ustna medicina d.o.o. — Ljubljana, Slovenia (RECRUITING)

Study contacts

• Principal investigator: Sebastjan Perko, PhD, DMD — Ustna medicina d.o.o.
• Study coordinator: Dominika Tompa Majcen, MPharm

Conditions: Gingivitis, hydrogen peroxide, mouth rinses, oral solutions