RecruitingNot ApplicableNCT07257887

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


Sponsor

ENIKAM d.o.o.

Enrollment

90 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called OROXID® forte oral solution, a medical device called OROXID® sensitive oral solution, and others for people with periodontal disease. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOROXID® forte oral solution

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

DEVICEOROXID® sensitive oral solution

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

OTHERStandard 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.


Locations(2)

Klinika Križaj Ljubljana

Ljubljana, Slovenia

Ustna medicina d.o.o.

Ljubljana, Slovenia

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NCT07257887


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