Background Denture-associated stomatitis is a common oral mucosal condition, with a reported prevalence ranging from 2.5–18.3% in adults aged 35–44 years and increasing to 35–50% in elderly populations. The condition is frequently associated with microbial colonization, poor oral hygiene, continuous denture wearing, and lifestyle factors such as smoking. Halitosis and oral inflammation are often linked to bacterial and fungal activity within the oral cavity. Conventional mouthwashes primarily provide temporary odor masking and are frequently non-swallowable, limiting their use in sensitive populations, particularly children and elderly patients. Natural products rich in phenolic and aromatic compounds offer promising alternatives due to their antimicrobial, anti-inflammatory, and antioxidant properties. Objective To clinically evaluate the efficacy and safety of a natural oral rinse formulated from Rosa damascena (Damask rose) hydrolate and Pistacia vera (pistachio) peel and gum extracts in reducing denture-associated stomatitis, halitosis, and oral inflammation, in alignment with the World Health Organization framework for traditional medicine. Study Design A randomized, double-blind, placebo-controlled clinical trial was designed. Participants:50 patients (aged 40–70 years) using removable dental prostheses and clinically diagnosed with denture-associated stomatitis. Intervention:Participants were randomly assigned into two groups: Test group: received the herbal oral rinse (Rosa damascena + Pistacia vera) Control group: received a placebo rinse identical in appearance, taste, and odor Dosage:10–15 mL rinse, used for at least 30 seconds, 2–3 times daily. Randomization and Blinding:Allocation was randomized, and both participants and clinicians were blinded to treatment assignment. Inclusion Criteria:Adults using removable dental appliances within the last three months, with confirmed diagnosis of denture-associated stomatitis. Exclusion Criteria:Hypersensitivity, systemic conditions affecting outcomes, concurrent interfering medications, or non-compliance with the study protocol. Outcome Measures Clinical efficacy was evaluated using standardized indices: Gingival Index (GI) Gingival Bleeding Index (GBI) Simplified Oral Hygiene Index (OHI-S) Gingival Swelling Index Safety monitoring included adverse event reporting and hypersensitivity assessment. Results The formulation demonstrated notable antimicrobial and antioxidant potential, supported by experimental and literature evidence: Pistachio peel extract exhibited measurable antibacterial activity against key oral pathogens, including Staphylococcus aureus, with inhibition zones up to 17.1 mm, indicating moderate-to-high antimicrobial efficacy compared to reference antibiotics. Minimum inhibitory concentrations (MIC) ranged from 0.5–2 mg/mL, confirming broad-spectrum activity against Gram-positive and Gram-negative bacteria. High phenolic content (up to 90.73 mg GAE/g extract) and antioxidant activity (DPPH scavenging up to 40.93%) support anti-inflammatory and protective effects in oral tissues. These findings suggest that the formulation effectively targets microbial and oxidative contributors to oral inflammation and halitosis. Discussion The clinical and experimental findings highlight the therapeutic potential of combining Rosa damascena and Pistacia vera extracts in oral healthcare applications. Rosa damascena contributes anti-inflammatory and antiseptic effects through its essential oil constituents (citronellol, geraniol, nerol), supporting mucosal healing. Pistacia vera provides phenolic and flavonoid compounds with proven antimicrobial and antioxidant activities, contributing to plaque control and reduction of gingival inflammation. The formulation addresses key limitations of conventional products by being natural, potentially ingestible, and multifunctional, offering antimicrobial, anti-inflammatory, analgesic, and deodorizing effects in a single preparation. Additionally, the study aligns with global trends promoting plant-based therapeutics and supports the integration of traditional medicine into modern clinical practice. Importantly, this work resulted in the granting of a patent for the developed oral formulation, confirming its novelty, innovation, and applicability in preventive and therapeutic oral care. Conclusion This study presents a novel, clinically evaluated natural oral rinse demonstrating promising efficacy in managing denture-associated stomatitis and halitosis. The formulation offers a safe, effective, and eco-friendly alternative to conventional oral antiseptics, with strong potential for integration into modern dental care.
Khatib et al. (Thu,) studied this question.