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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Slovenia
Klinika Križaj Ljubljana
RECRUITING
Ljubljana
Ustna medicina d.o.o.
RECRUITING
Ljubljana
Contact Information
Primary
Dominika Tompa Majcen, MPharm
dominika@enikam-oxy.com
+386 40 530 663
Time Frame
Start Date: 2025-11-22
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 90
Treatments
Experimental: OROXID® forte oral solution
Medical device: OROXID® forte oral solution
Experimental: OROXID® sensitive oral solution
Medical device: OROXID® sensitive oral solution
Other: Standard of Care
Oral solutions are not allowed
Related Therapeutic Areas
Sponsors
Leads: ENIKAM d.o.o.

This content was sourced from clinicaltrials.gov