Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07257887

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinika Križaj Ljubljana, Ljubljana, Slovenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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® 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.

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.

Primary outcomes

  1. Probing depth

    Time frame: Baseline and Week 12

    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.

  2. Bleeding on Probing (BOP)

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. Gingival Index (GI)

    Time frame: Baseline and Week 12

    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.

  2. Plaque Index (PI)

    Time frame: Baseline and Week 12

    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.

  3. Rate of infection

    Time frame: Up to week 12

    Incidence of infections in each group

  4. Adverse events

    Time frame: Throughout the 12-week study period

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominika Tompa Majcen, MPharm

CONTACT

[email protected]

+386 40 530 663

Sponsors and collaborators

Lead sponsor

ENIKAM d.o.o.

Industry

Registry information

Acronym: OroxParodont

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.