OROXID oral solution for treating periodontitis
Official title: Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis
Run by ENIKAM d.o.o. · NCT07257887 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | ENIKAM d.o.o. Industry-sponsored |
| Locations | 2 sites (Ljubljana and 1 other locations) |
| Status | Recruiting |
| Started | November 19, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07257887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: dominika@enikam-oxy.com
- Phone: +386 40 530 663
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adjuncts to non-surgical periodontal treatment in smokers and non-smokers with periodontitis
This trial tests whether adding I-PRF, povidone-iodine, or diode laser to standard deep cleaning helps reduce pocket depth and improve gum health in adults with periodontitis, including smokers.
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In adults who smoke and have stage III periodontitis, this study tests whether adding omega-3 fatty acids and a small amount of aspirin to standard cleaning helps improve gum health.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.