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

What this Trial Is About

Gingivitis is a reversible inflammation of the gums caused by dental plaque buildup. If untreated, it can worsen into periodontitis, which may lead to tooth loss. Managing gingivitis involves good oral hygiene, including tooth brushing and using interdental brushes, while more severe cases may require dental treatments like scaling or antibiotics. This study aims to evaluate the safety and effectiveness of hydrogen peroxide mouth rinses as an additional therapy for gingivitis, focusing on two concentrations: 1.5% (Oroxidae sensitive) and 3% (Oroxidae forte). Participants will be randomly assigned to one of three groups: using OROXIDae forte oral solution, OROXIDae sensitive oral solution, or receiving standard care involving tooth brushing without any mouth rinses. Those in the device groups will use the assigned oral solution two to three times daily for four weeks alongside standard care. The study compares these treatments to assess their impact on gum inflammation and oral hygiene. During the study, participants will be assessed at baseline, day 7, 14, and 28, measuring gingival health using the Gingival Index, Plaque Index, and Bleeding on Probing. Researchers will monitor infection rates and any adverse events throughout the 28-day period. Participants will follow oral hygiene instructions and provide informed consent before joining. The study provides detailed monitoring of gum health changes over a month to understand treatment effects.

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