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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-22

Study Completion Date

2026-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OROXID® forte oral solution

Medical device: OROXID® forte oral solution

Group Type EXPERIMENTAL

OROXID® forte oral solution

Intervention Type DEVICE

Patients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care.

OROXID® sensitive oral solution

Medical device: OROXID® sensitive oral solution

Group Type EXPERIMENTAL

OROXID® sensitive oral solution

Intervention Type DEVICE

Patients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care.

Standard of Care

Oral solutions are not allowed

Group Type OTHER

Standard of Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No