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This investigational product is a 5% green propolis mouthwash developed by the Federal University of Minas Gerais (UFMG) in Brazil for the treatment of gingivitis and dental plaque. The active ingredient is Brazilian green propolis extract, a natural product derived from bees that contains phenolic compounds including artepillin C, flavonoids, and other bioactive components with antibacterial and anti-inflammatory properties. The mouthwash formulation is alcohol-free and was manufactured by PharmaNéctar in Belo Horizonte, Brazil. The product's biological targets include pathogenic oral bacteria responsible for plaque formation and the inflammatory processes associated with gingivitis. As a natural product extract, it is classified as a botanical/natural product modality. The Phase 3 clinical trial is designed as a randomized, double-blind study comparing the 5% green propolis mouthwash to chlorhexidine, the gold standard antimicrobial mouthwash, for controlling dental plaque and gingivitis in adults.
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