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

NCT07257887 | Recruiting

• 1 other identifier: OROXID-PR-02-25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Periodontal Disease

Keywords

Periodontal Disease; hydrogen peroxide; mouth rinses

Outcome Measures

Primary Outcomes (2)

• Probing depth

  Mean change in probing depth (measured in millimeters) from baseline to Week 12, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. Probing Depth is the measurement of the distance from the gingival margin to the bottom of the periodontal pocket using a periodontal probe. Values typically range from 1-3 mm (healthy) to ≥5 mm (indicative of periodontal disease), with deeper pockets reflecting more severe attachment loss.

  Baseline and Week 12

• Bleeding on Probing (BOP)

  Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 12 weeks of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.

  Baseline and Week 12

Secondary Outcomes (4)

• Gingival Index (GI)

  Baseline and Week 12

• Plaque Index (PI)

  Baseline and Week 12

• Rate of infection

  Up to week 12

• Adverse events

  Throughout the 12-week study period

Study Arms (3)

OROXID® forte oral solution

EXPERIMENTAL

Medical device: OROXID® forte oral solution

Device: OROXID® forte oral solution

OROXID® sensitive oral solution

EXPERIMENTAL

Medical device: OROXID® sensitive oral solution

Device: OROXID® sensitive oral solution

Standard of Care

OTHER

Oral solutions are not allowed

Other: Standard of Care

Interventions

OROXID® forte oral solution DEVICE

Patients will use OROXID® forte oral solution two to three times daily for 12 weeks as an adjunct to standard care.

OROXID® forte oral solution

OROXID® sensitive oral solution DEVICE

Patients will use OROXID® sensitive oral solution two to three times daily for 12 weeks as an adjunct to standard care.

OROXID® sensitive oral solution

Standard of Care 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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy participants aged 18 years or older.
• Generalized periodontitis, Stage III, Grade B.
• Presence of three or more periodontal pockets deeper than 5 mm.
• At least 16 natural teeth (excluding wisdom teeth).
• Ability to comply with oral hygiene instructions following the intervention.
• Signed informed consent form after being fully informed about the study.

You may not qualify if:

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

Sponsors & Collaborators

• ENIKAM d.o.o.: lead

Study Sites (2)

Klinika Križaj Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Ustna medicina d.o.o.

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Urban Matoh, DMD

  Klinika Križaj Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominika Tompa Majcen, MPharm

CONTACT

+386 40 530 663; dominika@enikam-oxy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 2, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)