OROXID® oral solution for treating gingivitis
Official title: Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis
Run by ENIKAM d.o.o. · NCT07270705 · Data updated 2026-11-12
This test checks whether OROXID® oral solution (forte or sensitive) helps reduce gum inflammation and bleeding in adults with gingivitis.
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 22, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07270705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Peroxide-based and other active-oxygen mouth rinses have shown modest reductions in plaque and gingival inflammation in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- 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.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
Toothpaste for reducing dental plaque and preventing gum problems
This study tests three toothpaste options to see if they reduce plaque and gingivitis in adults with mild gum inflammation.
-
Effect of stannous fluoride toothpaste on gingival health indicators in an experimental gingivitis model
This study tests whether a toothpaste with stannous fluoride can influence gingival crevicular fluid biomarkers and help gingival tissue recover during early gingivitis.
-
Toothpaste that may reduce plaque and gingivitis in Chinese adults
A toothpaste test will be used to see if it reduces plaque and gingivitis more than a regular fluoride toothpaste in Chinese people with localized gingivitis.
-
Safety and effectiveness of an electric flosser with a manual toothbrush for gingivitis and plaque
This study tests whether using an electric interproximal flosser in addition to a manual toothbrush can reduce gingival inflammation and plaque in adults with gingivitis compared with brushing alone.
-
Bacterial Diversity in Gum Health With Fixed vs Removable Retainers After Braces
This study tests the gum microbiome and gum health in adults after braces, comparing fixed lingual retainers to removable Essix retainers.
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.