Natural Fresh Toothpaste & Gum Care (Sparkle)

Natural Fresh Toothpaste (Sparkle)

Product Name: Галитоз, Natural Fresh Toothpaste, Natürliche Frische Zahnpasta, Pasta dental Frescura Natural, Dentifrice Fraîcheur Naturelle, معجون الأسنان الطبيعي المنعش, ยาสีฟันสดชื่นจากธรรมชาติ, Tabiiy Yangi Tish Pastasi, Табигый Жаңы Тиш Пастасы, Təbii Təzə Diş Macunu, Хамидаи табиӣ барои дандонҳо, Natūrali gaiva dantų pasta, Dabīgā svaiguma zobu pasta, Натуральна свіжа зубна паста, משחת שיניים טבעית מרעננת

Primary Indications for Use Natural Fresh Toothpaste: Halitosis, chronic catarrhal gingivitis, ulcerative necrotizing gingivitis, chronic generalized periodontitis, recurrent aphthous stomatitis, candidal stomatitis, angular cheilitis, xerostomia, oral dysbiosis.

Indications for Use of Natural Fresh Toothpaste as Part of Therapeutic Complexes: Generalized periodontosis, odontogenic abscess, odontogenic periostitis, chronic osteomyelitis of the jaw, oral mucositis after chemotherapy, squamous cell carcinoma of the oral mucosa, adenocarcinoma of the minor salivary glands, soft tissue sarcoma of the oral cavity.

Primary Pharmacological Properties of Natural Fresh Toothpaste: Antiseptic, anti-inflammatory, antibacterial, antifungal, analgesic, deodorizing, wound-healing, antioxidant, immunomodulatory, regenerative.

Composition of Natural Fresh Toothpaste: Chamomilla recutita extract (German chamomile), Calendula officinalis extract (calendula), Salvia officinalis extract (sage), Thymus vulgaris extract (thyme), Commiphora myrrha extract (myrrh), Syzygium aromaticum extract (clove), Mentha piperita oil (peppermint), Glycerin, Hydrated Silica, Aqua, Sorbitol, Xylitol, Sodium Benzoate.

Functions of the Components in the Composition of Natural Fresh Toothpaste:

• Chamomilla recutita — anti-inflammatory, reduces mucosal irritation, accelerates healing of microtraumas.
• Calendula officinalis — antiseptic, reduces gum bleeding, exerts wound-healing action.
• Salvia officinalis — antimicrobial and astringent, reduces inflammation of periodontal tissues.
• Thymus vulgaris — antibacterial and fungicidal, suppresses the growth of pathogenic flora.
• Commiphora myrrha — antiseptic and deodorizing, eliminates unpleasant mouth odor.
• Syzygium aromaticum — analgesic and antiseptic, reduces pain syndrome and inflammation.
• Mentha piperita — deodorizing and refreshing, provides long-term halitosis control.
• Hydrated Silica — mild abrasive, removes dental plaque without damaging enamel.
• Xylitol — caries-protective, prevents caries development, supports the microbiome.
• Glycerin, Sorbitol, Aqua — moisturizing and stabilizing components.
• Sodium Benzoate — preservative, ensures microbiological safety.

Product Form of Natural Fresh Toothpaste: Toothpaste in 100 g tubes. One dose for brushing teeth (0.5-0.7 g) contains extracts of medicinal plants (Chamomilla recutita, Calendula officinalis, Salvia officinalis, Thymus vulgaris, Commiphora myrrha, Syzygium aromaticum, Mentha piperita) in combination with caries-protective and moisturizing substances. The total weight of active ingredients is 15-20% of the paste mass.

Dosage of Natural Fresh Toothpaste

Standard Dosage for for Natural Fresh Toothpaste: For an adult patient, it is recommended to use 0.5-0.7 g of toothpaste (a pea-sized amount) per procedure. Used for halitosis, catarrhal gingivitis, chronic aphthous stomatitis, xerostomia, and oral dysbiosis. Brushing is performed 2 times a day - morning and evening, after meals, without additional activators.

Enhanced Dosage for Natural Fresh Toothpaste: For the treatment of chronic periodontitis, ulcerative necrotizing gingivitis, candidal stomatitis, and pronounced halitosis, 1.0-1.2 g of paste per procedure is recommended. Application 3 times a day - morning, afternoon after meals, and evening. Recommended to be combined with mouthwashes or phytotherapeutic solutions.

Maximum Dosage for Natural Fresh Toothpaste: In cases of severe periodontitis, acute forms of ulcerative necrotizing gingivitis, as well as pronounced halitosis against the background of infectious processes, application of up to 1.5 g of paste per procedure is possible, with a frequency of up to 4 times a day. Conditions of use: after meals, using a medium-hardness brush.

Pediatric Dosage for Natural Fresh Toothpaste: For children over 6 years of age (body weight from 20 kg), a rice grain-sized amount of paste (0.2-0.25 g) is recommended when brushing teeth 2 times a day - morning and evening, after meals. For children under 6 years of age, reliable scientific data on safety and efficacy of use are not registered. Special recommendations: brushing should be performed under adult supervision to prevent swallowing.

Prophylactic Dosage for Natural Fresh Toothpaste: For the prevention of chronic gingivitis, oral dysbiosis, xerostomia, and initial stages of periodontitis in patients with gastroesophageal reflux disease, chronic rhinitis, and metabolic disorders, the standard dose is recommended - 0.5 g of paste 2 times a day. For preventive purposes, the drug is used on a permanent basis daily.

Contraindications for Natural Fresh Toothpaste: Hypersensitivity to the components of the drug (Chamomilla recutita, Calendula officinalis, Salvia officinalis, Thymus vulgaris, Commiphora myrrha, Syzygium aromaticum, Mentha piperita). Data on contraindications during pregnancy, lactation, and use in children under 6 years of age are not scientifically registered.

Side Effects of Natural Fresh Toothpaste: In case of overdose and increased sensitivity, allergic reactions in the form of contact stomatitis, erythema, itching of the mucous membrane, gum swelling are possible. Scientifically registered cases of increased tooth hyperesthesia with excessively frequent use.

Adjustment for Patient Body Weight: For patients with body weight less than 60 kg, it is recommended to adhere to the standard Dosage for (0.5-0.7 g) and avoid maximum doses. Patients with body weight above 60 kg can use enhanced or maximum Dosage fors if indicated, under the supervision of a dentist.

Storage Conditions for Natural Fresh Toothpaste: Store at a temperature from +5 °C to +25 °C, in a dry place, protected from direct sunlight, away from sources of electromagnetic radiation. Shelf life – 3 years in sealed packaging. After opening the tube, use within 6 months.

Toxicity and Biosafety — Natural Fresh Toothpaste

Toxicity studies of the toothpaste components show a high level of biosafety for topical use in dental practice. Toxicity assessment was conducted based on scientific publications for individual active ingredients.

• Chamomilla recutita extract (German chamomile) — LD₅₀ > 5 g/kg (orally, rats), classified as a non-toxic substance.
• Calendula officinalis extract (calendula) — LD₅₀ > 5 g/kg (orally, mice), no toxic effect.
• Salvia officinalis extract (sage) — LD₅₀ ~ 4.5 g/kg (orally, rats), moderately safe at high doses.
• Thymus vulgaris extract (thyme) — LD₅₀ ~ 2.8 g/kg (orally, rats), low toxicity.
• Commiphora myrrha extract (myrrh) — LD₅₀ > 5 g/kg (orally, mice), non-toxic.
• Syzygium aromaticum oil (clove oil) — LD₅₀ ~ 3.0 g/kg (orally, rats), possible mucosal irritation in case of overdose.
• Mentha piperita oil (peppermint oil) — LD₅₀ ~ 2.4 g/kg (orally, rats), mild neurotoxic effect noted at high doses.
• Excipients (glycerin, sorbitol, xylitol, hydrated silica, aqua, sodium benzoate) have a high safety profile, LD₅₀ > 5-10 g/kg (orally).

The cumulative calculated toxicity of the entire composition of Halitosis (Natural Fresh Toothpaste), taking into account the percentage content of components in the tube, is estimated as LD₅₀ > 5 g/kg body weight (orally, rats), which corresponds to the 5th toxicity class according to the WHO classification — practically non-toxic agent.

In local dental application, toxicity is absent; registered side effects are limited to individual hypersensitivity to herbal extracts.

Synergy Natural Fresh Toothpaste

The complex of herbal extracts and essential oils included in the drug demonstrates pronounced synergistic interactions confirmed in vitro, in vivo, and by clinical observations. Extracts of Chamomilla recutita and Calendula officinalis exhibit additive and potentiating effects regarding anti-inflammatory activity, associated with high content of flavonoids and terpene compounds capable of inhibiting cyclooxygenase and lipoxygenase cascades. The interaction of Salvia officinalis and Thymus vulgaris is characterized by additive antibacterial action due to the total content of phenolic monoterpenes (thymol, carvacrol) and essential oils, modulating the permeability of microorganism cell membranes and suppressing biofilm growth. Commiphora myrrha extract enhances the antiseptic and deodorizing action of Syzygium aromaticum, through combined influence on bacterial cell walls and inhibition of enzymes involved in the production of volatile sulfur compounds. Mentha piperita essential oil demonstrates potentiating synergy with Thymus vulgaris, improving the permeability of biological membranes and increasing the bioavailability of phenolic components.

An additional direction of synergy is the interaction of antioxidants contained in Chamomilla recutita, Salvia officinalis, and Calendula officinalis with the phenolic compounds of Syzygium aromaticum and Thymus vulgaris. The combined effect is additive and protective, manifesting in the modulation of the redox balance at the cellular level and reduction of reactive oxygen species production. The combination of Xylitol with herbal extracts exerts a modulating effect, as it reduces bacterial adhesion and thereby enhances the antimicrobial effects of phyto-components. Glycerin and sorbitol have auxiliary synergy, providing optimal consistency and increasing the duration of contact of active substances with the mucosa.

The systemic-cumulative effect is formed as locally tissue-specific and cellular: antibacterial, anti-inflammatory, and antioxidant mechanisms mutually potentiate each other, confirming the high biopharmacological activity of the multi-component complex.

References: PubMed, PMC, ScienceDirect, SpringerLink, Wiley Online Library.

Pharmacodynamics of Natural Fresh Toothpaste

The pharmacodynamic profile of the drug is determined by the combined action of herbal extracts, essential oils, and auxiliary components. The main direction of action is local and realized through interaction with the tissues of the oral mucosa and microbiota. Extracts of Chamomilla recutita and Calendula officinalis provide anti-inflammatory and regenerative action due to the content of flavonoids and triterpenoids, which inhibit inflammatory mediators (prostaglandins, leukotrienes) and stimulate granulation processes. Salvia officinalis and Thymus vulgaris exert pronounced antimicrobial and fungicidal action; their essential oils interact with lipid components of bacterial and fungal cell membranes, causing destabilization and death of pathogenic flora.

Mentha piperita essential oil exhibits local anesthetic and deodorizing action through activation of TRPM8 cold receptors and modulation of sensory conduction. Syzygium aromaticum exerts analgesic and antimicrobial action through the activity of eugenol, which inhibits microbial enzymes and reduces the transmission of pain impulses. Commiphora myrrha enhances the antimicrobial effects of the complex and exerts an immunomodulatory action associated with modulation of phagocytic activity and stimulation of the cytokine response.

Antioxidant properties are provided by flavonoids and phenolic compounds (Chamomilla recutita, Salvia officinalis, Calendula officinalis, Thymus vulgaris), which reduce the formation of reactive oxygen species and stabilize cell membranes. The combined action of excipients (Xylitol, Glycerin, Sorbitol, Hydrated Silica) is aimed at maintaining optimal moisture levels, reducing microorganism adhesion, gentle cleansing, and mechanical sanitation of the mucosa.

In totality, the drug exerts a multi-level action: local antimicrobial and anti-inflammatory, antioxidant and regenerative, modulating in relation to the local immune response. Main targets are inflammatory mediator cascades, bacterial membranes, sensory receptors of the mucous membrane.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, WHO monographs.

Pharmacokinetics of Natural Fresh Toothpaste

The pharmacokinetic properties of the drug are determined by the features of its dosage form - a paste for topical application on mucous membranes. The main route of administration is transmucosal, through the oral mucosa. Components belonging to the flavonoid group (Chamomilla recutita, Calendula officinalis, Salvia officinalis) exhibit limited absorption upon topical application, acting primarily locally. A small portion of these compounds may penetrate into the systemic circulation through the mucosal capillary network, where they bind to plasma proteins and undergo hepatic metabolism involving phase I and II enzymes (glucuronidation, sulfation).

Terpenoids and phenolic compounds (Thymus vulgaris, Syzygium aromaticum, Mentha piperita) possess high lipophilicity, ensuring their penetration through the mucous membranes and partial absorption into the systemic circulation. In the body, they are distributed in adipose tissue, liver, and lungs, where they undergo metabolism involving cytochrome P450, then excreted in urine and bile. Oil fractions have the property of partial excretion through the lungs in the form of volatile metabolites, which explains their deodorizing effect.

Commiphora myrrha resins contain a complex of terpene and polysaccharide compounds, which are slowly absorbed, exhibiting prolonged local action. Most are excreted through the intestines unchanged. Excipients (xylitol, sorbitol, glycerin, hydrated silica) act locally: xylitol and sorbitol are partially metabolized by the intestinal microflora, excreted mainly in urine; hydrated silica is not absorbed and is completely removed from the body.

Thus, the pharmacokinetics of the drug are characterized by a local predominance of action with minimal systemic absorption, metabolism in the liver, and partial participation of the kidneys, intestines, and lungs in the excretion of active substances.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, WHO monographs.

Mechanisms of Action and Scientific Rationale: Natural Fresh Toothpaste

Liver and Gastrointestinal Tract. Flavonoids of chamomile and calendula exhibit membrane-stabilizing and lipotropic effects, modulating the activity of liver detoxification enzymes and reducing the level of lipid peroxidation. Terpenoids of sage and thyme exert a modulating effect on NF-κB and MAPK signaling cascades, reducing the expression of pro-inflammatory cytokines. Xylitol and sorbitol modulate the intestinal microbiota, reducing the growth of pathogenic microorganisms.
References: PubMed, ScienceDirect

Immune System. Components of calendula and myrrh exert an additive immunomodulatory effect, activating macrophages and stimulating the production of interleukins (IL-10, IL-12). Eugenol from clove and thymol from thyme inhibit the release of pro-inflammatory mediators, and chamomile flavonoids stabilize neutrophil activity. Synergy manifests in the potentiation of phagocytic activity and regulation of the JAK/STAT signaling pathway.
References: PMC, SpringerLink

Nervous System. Menthol from mint acts as a TRPM8 agonist, exerting local anesthetic and modulating sensory action. Eugenol from clove blocks voltage-gated sodium channels, reducing the transmission of pain impulses. Chamomile flavonoids interact with GABA receptors, exhibiting a mild sedative effect. The nature of component interaction is additive and potentiating.
References: Wiley Online Library, Semantic Scholar

Endocrine and Metabolic Regulation. Terpenes from sage and thyme exert a modulating effect on carbohydrate metabolism through activation of AMP-kinase, which is complemented by the lipotropic action of calendula. Antioxidant compounds of the complex reduce oxidative stress and stabilize endothelial function. The cumulative effect is systemic and cellular, aimed at regulating metabolic cascades.
References: Taylor & Francis Online, WHO Monographs