OROXID oral solution for treating periodontitis

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

This trial will test whether using OROXID oral solutions (forte or sensitive) alongside regular dental cleaning helps adults with Stage III, Grade B periodontitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ENIKAM d.o.o. (Industry-sponsored)
• Locations: 2 sites (Ljubljana and 1 other locations)
• Trial ID: NCT07257887 on ClinicalTrials.gov

What this trial studies

Adults with generalized Stage III, Grade B periodontitis will be assigned to receive either OROXID forte oral solution, OROXID sensitive oral solution, or standard of care as an adjunct to routine mechanical periodontal therapy. The study will monitor clinical periodontal measures (such as pocket depth and attachment levels) and record any adverse effects related to the mouth rinses. Participants must be systemically healthy, have at least 16 natural teeth, and present multiple pockets deeper than 5 mm. The trial aims to collect safety and efficacy data on topical hydrogen peroxide–based oral solutions as an adjunct to mechanical plaque control.

Who should consider this trial

Good fit: Ideal candidates are systemically healthy adults (18+) with generalized Stage III, Grade B periodontitis who have at least three pockets >5 mm and at least 16 natural teeth and who can follow oral hygiene instructions.

Not a fit: People with Stage IV periodontitis, recent periodontal treatment or antibiotic use, significant systemic diseases (e.g., diabetes, HIV, liver or kidney disease), or on certain cardiovascular medications are unlikely to qualify or benefit from this intervention.

Why it matters

Potential benefit: If successful, OROXID could reduce pocket depths and bacterial biofilm activity, helping slow disease progression and potentially preserve teeth with a non‑invasive adjunct.

How similar studies have performed: Hydrogen peroxide and antiseptic mouth rinses have shown modest benefits for plaque and gingivitis in prior studies, but high‑quality evidence for improving established periodontitis outcomes is limited.

Eligibility criteria

Inclusion Criteria:

1. Systemically healthy participants aged 18 years or older.
2. Generalized periodontitis, Stage III, Grade B.
3. Presence of three or more periodontal pockets deeper than 5 mm.
4. At least 16 natural teeth (excluding wisdom teeth).
5. Ability to comply with oral hygiene instructions following the intervention.
6. Signed informed consent form after being fully informed about the study.

Exclusion Criteria:

1. Periodontal treatment within the past six months.
2. Dental procedures (surgery, professional cleaning, scaling and root planing, laser therapy, piezotome) within the past six months.
3. Periodontitis, Stage IV.
4. Use of mouth rinses or oral gels within the past month.
5. Use of antibiotic therapy within the past three months.
6. Ongoing therapy with antihypertensives, antilipemics, antiarrhythmics, or other cardiovascular medications.
7. Systemic diseases such as diabetes, HIV/AIDS, liver diseases, chronic kidney disease, tuberculosis, and autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease).
8. History of cardiovascular diseases, including acute myocardial infarction, angina pectoris, heart failure, atrial fibrillation, atrioventricular block, peripheral artery disease, or stroke.
9. Therapy with immunosuppressive agents.
10. Allergy to any ingredients of the study products.
11. Pregnant or breastfeeding women.

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: Urban Matoh, DMD — Klinika Križaj Ljubljana
• Study coordinator: Dominika Tompa Majcen, MPharm

Conditions Periodontal Disease; hydrogen peroxide; mouth rinses