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

NCT07270705 | Recruiting

• 1 other identifier: OROXID-PR-03-25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Gingivitis

Keywords

Gingivitis; hydrogen peroxide; mouth rinses; oral solutions

Outcome Measures

Primary Outcomes (3)

• Gingival Index (GI) at Day 7

  Mean change in Gingival Index (Silness and Löe) scores from baseline to day 7, 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 Day 7

• Plaque Index (PI) at Day 7

  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 Day 7

• Bleeding on Probing (BOP) at Day 7

  Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 7 days 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 Day 7

Secondary Outcomes (5)

• Gingival Index (GI) at Day 14 and 28

  Baseline, Day 14, and Day 28

• Plaque Index (PI) at Day 14 and 28

  Baseline, Day 14, and Day 28

• Bleeding on Probing (BOP) at Day 14 and 28

  Baseline, Day 14, and Day 28

• Rate of infection

  Baseline to Day 28

• Adverse events

  Baseline to Day 28

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 4 weeks as an adjunct to standard care.

OROXID® forte 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

OROXID® sensitive oral solution DEVICE

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

OROXID® sensitive oral solution

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.
• Presence of at least 20 natural teeth.
• Probing pocket depth less than or equal to 3 mm.
• Presence of bleeding on probing in more than 10% of sites.
• Mean Gingival Index (Silness \& Löe) of at least 1.
• Ability and willingness to follow oral hygiene instructions after the intervention.
• Signed informed consent form after being informed about the study.

You may not qualify if:

• Periodontal treatment within the last three months.
• Diagnosis of periodontitis.
• Use of mouth rinses or oral gels within the last month.
• Use of antibiotic therapy within the last three months.
• Known allergy or hypersensitivity to any components of the investigational products.
• Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications.
• 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).
• Use of immunosuppressive medications.
• Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture.
• Pregnant or breastfeeding women.
• Smokers.

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

Gingivitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; 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

• Sebastjan Perko, PhD, DMD

  Ustna medicina d.o.o.

  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 8, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)