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

ENIKAM d.o.o.

Status: Enrolling

Conditions: Gingivitis

Treatments: Other: Standard of Care; Device: OROXID® sensitive oral solution; Device: OROXID® forte oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT07270705

OROXID-PR-03-25

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

OROXID® forte oral solution

Experimental group

Description:

Medical device: OROXID® forte oral solution

Treatment:

Device: OROXID® forte oral solution

OROXID® sensitive oral solution

Experimental group

Description:

Medical device: OROXID® sensitive oral solution

Treatment:

Device: OROXID® sensitive oral solution

Standard of Care

Other group

Description:

Oral solutions are not allowed

Treatment:

Other: Standard of Care