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

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).

Study Overview

• Status: Recruiting
• Conditions: Periodontal Disease
• Intervention / Treatment: Device: OROXID® forte oral solution; Device: OROXID® sensitive oral solution; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominika Tompa Majcen, MPharm; Phone Number: +386 40 530 663; Email: dominika@enikam-oxy.com

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Klinika Križaj Ljubljana
    • Contact: Urban Matoh, DMD; Phone Number: 0038651224900; Email: urban.matoh@siol.net
    • Principal Investigator: Urban Matoh, DMD
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Ustna medicina d.o.o.
    • Contact: Sebastjan Perko, PhD, DMD; Phone Number: 0038612323235; Email: info@ustna-medicina.com
    • Principal Investigator: Sebastjan Perko, PhD, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OROXID® forte oral solution; Medical device: OROXID® forte oral solution	Device: OROXID® forte oral solution; Patients will use OROXID® forte oral solution two to three times daily for 12 weeks as an adjunct to standard care.
Experimental: OROXID® sensitive oral solution; Medical device: OROXID® sensitive oral solution	Device: OROXID® sensitive oral solution; Patients will use OROXID® sensitive oral solution two to three times daily for 12 weeks as an adjunct to standard care.
Other: Standard of Care; Oral solutions are not allowed	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index (GI)	Mean change in Gingival Index (Silness and Löe) scores from baseline to Week 12, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing.	Baseline and Week 12
Plaque Index (PI)	Differences in Plaque Index (PI) scores between the active and control groups will be evaluated using the Silness and Löe Plaque Index. This index assesses the thickness of dental plaque along the gingival margin based on the following scoring criteria: Score 0 = No plaque score; 1 = Mild plaque along the gingival margin; Score 2 =Moderate layer of plaque along gingival margin, interdental spaces free; Score 3 = Abundant plaque along the gingival margin, interdental spaces filled with plaque. Higher scores indicate poorer oral hygiene and greater plaque accumulation.	Baseline and Week 12
Rate of infection	Incidence of infections in each group	Up to week 12
Adverse events	Number and percentage of participants experiencing adverse events (AEs) related to the use of OROXID® forte or OROXID® sensitive during the 12-week study period. The nature, severity, and relationship of each AE to the study product will be recorded and analyzed.	Throughout the 12-week study period

Collaborators and Investigators

• Sponsor: ENIKAM d.o.o.
• Investigators: Principal Investigator: Urban Matoh, DMD, Klinika Križaj Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Periodontal Disease; hydrogen peroxide; mouth rinses
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: OROXID-PR-02-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

As a company operating under the jurisdiction of the EU, the organization is subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. Individual Participant Data (IPD) from clinical trials is considered sensitive personal data under GDPR.

Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, the sharing of IPD is not permitted.

For this reason, and to ensure full compliance with EU data protection regulations while safeguarding the privacy and rights of study participants, individual-level data cannot currently be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No