Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis (OroxParodont)

ENIKAM d.o.o.

Status: Enrolling

Conditions: Periodontal Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07257887

OROXID-PR-02-25

Details and patient eligibility

About

Periodontitis is a chronic, irreversible inflammatory disease affecting the supporting structures of the teeth. It is most commonly caused by bacteria in dental plaque, also known as biofilm. The disease typically begins as gingivitis, a reversible inflammation of the gums resulting from plaque accumulation. Without appropriate intervention-such as maintaining proper oral hygiene and removing plaque-gingivitis can progress to periodontitis, leading to the loss of clinical attachment, alveolar bone resorption, and eventually tooth loss.

Early diagnosis and regular treatment of periodontal disease are essential to prevent disease progression. The treatment of periodontitis is primarily causal and involves the mechanical removal of plaque. Initial therapy is non-surgical, consisting of scaling and root planing, and may be followed by surgical procedures if required. In addition to mechanical cleaning, increasing attention has been given to adjunctive, non-invasive therapies such as mouth rinses or oral solutions containing chlorhexidine or hydrogen peroxide. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing.

Hydrogen peroxide mouth rinses have been used for more than a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. However, despite their long history of use, clinical studies evaluating hydrogen peroxide-based mouth rinses remain limited and heterogeneous in design, which makes it difficult to compare findings across studies.

The objective of this post-marketing clinical study is to generate additional data on the safety and efficacy of a hydrogen peroxide mouth rinse as an adjunctive therapy in the treatment of periodontitis. The study will evaluate two hydrogen peroxide concentrations: 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. Generalized periodontitis, Stage III, Grade B.
3. Presence of three or more periodontal pockets deeper than 5 mm.
4. At least 16 natural teeth (excluding wisdom teeth).
5. Ability to comply with oral hygiene instructions following the intervention.
6. Signed informed consent form after being fully informed about the study.

Exclusion criteria

1. Periodontal treatment within the past six months.
2. Dental procedures (surgery, professional cleaning, scaling and root planing, laser therapy, piezotome) within the past six months.
3. Periodontitis, Stage IV.
4. Use of mouth rinses or oral gels within the past month.
5. Use of antibiotic therapy within the past three months.
6. Ongoing therapy with antihypertensives, antilipemics, antiarrhythmics, or other cardiovascular medications.
7. Systemic diseases such as diabetes, HIV/AIDS, liver diseases, chronic kidney disease, tuberculosis, and autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease).
8. History of cardiovascular diseases, including acute myocardial infarction, angina pectoris, heart failure, atrial fibrillation, atrioventricular block, peripheral artery disease, or stroke.
9. Therapy with immunosuppressive agents.
10. Allergy to any ingredients of the study products.
11. Pregnant or breastfeeding women.

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