Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OROXID® forte oral solution, OROXID® sensitive oral solution, Standard of Care.
- Who it may be relevant to
- Registry conditions: Gingivitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult. One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).
Interventions
- Device OROXID® forte oral solution
Patients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care. - Device OROXID® sensitive oral solution
Patients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care. - Other Standard of Care
Patients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load.
Primary outcome measures
- Gingival Index (GI) at Day 7 [Time frame: Baseline and Day 7]
- Plaque Index (PI) at Day 7 [Time frame: Baseline and Day 7]
- Bleeding on Probing (BOP) at Day 7 [Time frame: Baseline and Day 7]
Secondary outcome measures (5)
- Gingival Index (GI) at Day 14 and 28 [Time frame: Baseline, Day 14, and Day 28]
- Plaque Index (PI) at Day 14 and 28 [Time frame: Baseline, Day 14, and Day 28]
- Bleeding on Probing (BOP) at Day 14 and 28 [Time frame: Baseline, Day 14, and Day 28]
- Rate of infection [Time frame: Baseline to Day 28]
- Adverse events [Time frame: Baseline to Day 28]
Eligibility criteria
Inclusion criteria
- Systemically healthy participants aged 18 years or older.
- Presence of at least 20 natural teeth.
- Probing pocket depth less than or equal to 3 mm.
- Presence of bleeding on probing in more than 10% of sites.
- Mean Gingival Index (Silness \& Löe) of at least 1.
- Ability and willingness to follow oral hygiene instructions after the intervention.
- Signed informed consent form after being informed about the study.
Exclusion criteria
- Periodontal treatment within the last three months.
- Diagnosis of periodontitis.
- Use of mouth rinses or oral gels within the last month.
- Use of antibiotic therapy within the last three months.
- Known allergy or hypersensitivity to any components of the investigational products.
- Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications.
- 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).
- Use of immunosuppressive medications.
- Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture.
- Pregnant or breastfeeding women.
- Smokers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 2 centers
- Klinika Križaj Ljubljana — Ljubljana
- Ustna medicina d.o.o. — Ljubljana
Identifiers
NCT: NCT07270705 · OROXID-PR-03-25