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

RecruitingNAAges 18 Years - anyAllENIKAM d.o.o.
NCT07270705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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.
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What it tests

  • OROXID® forte oral solution
  • OROXID® sensitive oral solution
  • Standard of Care
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Where

2 sites
Klinika Križaj Ljubljana
Ljubljana, Slovenia
Ustna medicina d.o.o.
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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