P80 natural essence spray and lozenges provide respiratory protection against Influenza A, B, and SARS-CoV-2.

Seasonally circulating viruses, such as Influenza, as well as newly emerging viruses and variants thereof, and waning immunity urge the need for safe, easy-to-use and inexpensive drugs to protect from these challenges. To prevent transmission of these viruses and subsequent excessive inflammatory reactions on mucous membranes, we tested the efficacy of the natural essence P80 as spray and in form of lozenges against respiratory infections caused by SARS-CoV-2 variants of concern (VoCs), influenza A (H3N2) and influenza B (Victoria). P80 natural essence, a Dimocarpus longan extract, shielded highly differentiated human airway epithelia from SARS-CoV-2 wildtype and Omicron variant as well as Influenza A and B infection and dampened inflammation by down-modulating pro-inflammatory cytokine and anaphylatoxin secretion. A single application of P80 natural essence spray maintained tissue integrity long-term. This also significantly reduced the release of infectious viral particles and the secretion of IP10, MCP1, RANTES and C3a, all of which mediate the migration of immune cells to the sites of infection. Even P80 lozenges dissolved in distilled water or non-neutralizing saliva efficiently prevented SARS-CoV-2 and Influenza-induced tissue destruction. Consequently, our in vitro data suggest that P80 natural essence can act as antiviral prophylactic, both in form of nasal or oral spray and in form of lozenges, independent of circulating respiratory challenges.

Short-term use of Lacticaseibacillus rhamnosus SD11 and the oral microbiome: Low caries RCT study.

OBJECTIVES: The objective of the study was to investigate the effect of short-term lozenges containing Lacticaseibacillus rhamnosus SD11 on cariogenic pathogens and on oral microbiota. MATERIALS AND METHODS: This double-blind, randomized, controlled trial included 121 subjects and was randomly divided into the control and probiotic group. All subjects were blindly administered to receive the control- or probiotic L. rhamnosus SD11 lozenges every day for 4 weeks and then followed up for another 4 weeks. RESULTS: After probiotic consumption, the probiotic group had significantly lower levels of Streptococcus mutans and significantly higher levels of total lactobacilli at 4 and 8 weeks compared with the baseline. The 16S rRNA sequencing revealed an increase in bacterial diversity and beneficial bacteria in the Firmicutes phylum, Bacilli class, and a reduction in the mutans streptococci group in the probiotic group. The opposite results were found in the control group. This study did not find any caries increment, nor did the subjects have any side effects after product consumption. CONCLUSION: With the limitation of a short-time study in low caries children, it showed that L. rhamnosus SD11 could increase beneficial bacteria in the Firmicutes phylum and Bacilli class that might support good oral health in children.

Use of Emerging and Conventional Oral Tobacco Among Adolescent and Young Adult E-Cigarette Users.

Background: National surveillance assessing use of novel oral tobacco products (OTPs; nicotine pouches, lozenges, and gums not approved for tobacco cessation) among adolescents and young adults is limited. Objectives: To assess OTP behaviors in a sample of adolescent and young adult e-cigarette users, including use prevalence, dual/poly use with other products, and associated demographics. Methods: A national (United States) cross-sectional survey was conducted from March to April 2021 among 2253 participants (ages 14-20; 65% female) who ever used e-cigarettes ≥3 times. Demographics, lifetime use, and past 30-day use of 10 tobacco and cannabis products, including novel and conventional (chew, moist snuff, or snus) OTPs was assessed. Analysis was descriptive, examining use prevalence (lifetime and past 30-day) of each product, including by demographics and other product use. Results: Nearly 44% reported ever using any OTP, with nicotine pouches being the most commonly ever used (29%) and used in the past month (11%). Novel OTP use was more common among older participants (18-20 years), male participants, and past 30-day users of e-cigarettes, combustible tobacco, and conventional oral tobacco. However, female participants and combustible tobacco non-users were over twice and 4-times as likely, respectively, to use novel OTPs than conventional OTPs. Nearly 73% of past 30-day conventional OTP users were past 30-day novel OTP users. Conclusion: Novel OTP use was prevalent among adolescent and young adult e-cigarette users. Compared to conventional OTPs, novel OTPs likely have greater appeal to females and combustible tobacco non-users. Action to restrict access and reduce interest in OTPs is needed to prevent use among this population.

Long-term safety and efficacy of sublingual ketamine troches/lozenges in chronic non-malignant pain management.

BACKGROUND: Chronic non-malignant pain is a disabling condition that results in a reduction in function and quality of life when inadequately managed. Sublingual ketamine has been shown to be efficacious for use in chronic pain. Despite its use for decades in chronic non-malignant pain, there is no published long-term data on safety, side-effects or adverse drug reactions. AIM: The aim of this case-series is to provide the initial evidence for safety and efficacy in this patient group. METHODS: We present a retrospective review of 29 (n = 29) patients from a metropolitan tertiary pain service who have been receiving sublingual ketamine troches/lozenges between the period of 2012 and 2019. Patients were identified from the outpatient pain clinic, who had been admitted for inpatient subcutaneous ketamine infusions as part of opiate detoxification or management of central sensitisation due to a chronic neuropathic pain syndrome. An initial review was performed to check the patient started taking the ketamine troches. Each of these medical records was reviewed manually to extract information to a datasheet. RESULTS: There was a wide range of dosages used from 25 to 600 mg in divided doses. The duration of treatment ranged 2-89 months. There was no association with either the dosage or duration of treatment and frequency of side-effects. There was an overall reduction in the use of opioids, gabapentinoids or benzodiazepines in 59% of patients with 39% having a complete cessation of an analgesic agent. Side-effects were reported in 24%, but only 7% discontinued the treatment due to the side-effect (drowsiness). There were no reports of renal impairment, cystitis or hepatotoxicity. DISCUSSION: This retrospective case-series has demonstrated that sublingual ketamine is a safe and effective analgesic agent to use in chronic non-malignant pain management. It is indicated in a variety of chronic pain conditions and has an excellent safety profile, with no association between the frequency in side-effects and duration of therapy or total daily dosages. The study has also shown that the 'safe' dose may be higher than the previous consensus.

Prenatal developmental toxicity study of 2,4-dichlorobenzyl alcohol in rats.

Sore throat lozenges, which are over-the-counter drugs, contain 2,4-dichlorobenzyl alcohol (DCBA) as the primary ingredient. However, comprehensive data on the prenatal developmental toxicity of DCBA is limited. Therefore, this study was conducted to determine the effects of DCBA on pregnant rats and prenatal development. Sprague-Dawley rats were administered different doses of DCBA (0, 25, 100, 400, and 800 mg/kg/day) daily via an oral gavage from gestation day (GD) 6-19. Thereafter, all the live dams were sacrificed on GD 20, and caesarean sections were conducted. Live fetuses and their placenta were weighed and then examined for external, visceral, and skeletal malformations and variations. Based on the results obtained, dams at 800 mg/kg/day showed systemic toxicities, including a decrease in body weight and food consumption, and liver changes. Additionally, this treatment induced decreases in fetal and placental weights, as well as the increased incidence of retarded ossifications and full supernumery rib, and the decreased number of ossification centers. Therefore, based on these findings, the no-observed-adverse-effect level of DCBA was determined to be 400 mg/kg/day for dams and prenatal development.

A Comparative Study to Evaluate the Efficacy of Curcumin Lozenges (TurmNova®) and Intralesional Corticosteroids with Hyaluronidase in Management of Oral Submucous Fibrosis.

AIM AND OBJECTIVE: This study aims to compare the efficacy of TurmNova® lozenges and its active ingredient "curcumin" as a low-cost, safe, and noninvasive chemopreventive agent with intralesional corticosteroids (with hyaluronidase) in the management of oral submucous fibrosis (OSMF). MATERIALS AND METHODS: A total of 80 patients with group III OSMF (Khanna JN and Andrade NN classification) visiting the dental outpatient clinic of the Department of Oral Medicine and Radiology Rama Dental College Hospital and Research Center, Kanpur, were selected for the study. A total of 80 patients were randomly divided into two groups (40 participants each): group A to whom TurmNova® lozenges containing turmeric extract 100 mg along with clove oil 10 mg three times daily for 3 months were given and group B to whom intralesional infiltration of 2 mL dexamethasone (4 mg/mL) + hyaluronidase 1500 IU dissolved in 0.5 mL of 2% lignocaine twice a week for 3 months was given. Data were analyzed using the IBM SPSS Statistics, version 21 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, version 21.0. Armonk, New York: IBM Corp.) Results: Statistical analysis revealed that there was significant clinical improvement in mouth opening and subjective symptoms, like burning sensation/pain associated with the lesion and tongue protrusion in the group A as compared to group B. CONCLUSION: Curcumin (100 mg) in an innovative delivery system of lozenge results in a higher level of plasma curcumin level. The aforementioned dosages prevent its biotransformation and inactivation by the liver enzymes. Because of these properties, curcumin lozenges are safer, low-cost, and effective alternative treatment in contrast to the present traditional treatment. Further long-term, prospective, large-scale studies need to be done. CLINICAL SIGNIFICANCE: Curcumin has a role in the treatment of oral premalignant conditions and acts as a very effective chemopreventive agent in the prevention of cancer.

Formulation development of anti-stress compressed lozenges using a fractional factorial Latin cube design and ANOVA approach.

The aim of this work was to develop anti-stress compressed lozenges containing 100 mg of glycine and 250 mg of magnesium citrate obtained by the direct compression method. To choose optimal excipient composition providing the sufficient pharmaco-technical properties of the tablet blend, mechanical strength of tablets and non-disintegrating, slow-dissolving behavior of compressed lozenges during sucking, 27 experimental formulations according to fractional factorial Latin cube design were prepared and tested. The excipients used in the study were: Mannogem® EZ, Cellactose® 80 and GalenIQ 721 (fillers); Plasdone S-630, Kollidon® 90 F and Avicel® PH-101 (dry binders); Metolose® 90SH-4000SR and guar gum (gel-forming binders); PRUV®, Neusilin® US2, and Compritol® 888 CG ATO (antifriction excipients). The following parameters were investigated as responses: bulk density, Carrs index, friability, resistance to crushing, and in vitro disintegration time. ANOVA approach was applied for statistical processing, which allowed to reveal the individual effects of each excipient and several interaction effects observed for the excipient amounts used in this study. Isomalt (GalenIQ 721), copovidone (Plasdone S-630), and glyceryl behenate (Compritol® 888 CG ATO) were selected to be incorporated in the final formulation of compressed lozenges.

Green HPTLC and stability-indicating RP-HPLC for the assay of dextromethorphan hydrobromide and menthol in their lozenges.

Two chromatographic methods were developed for the assay of the FDA approved lozenges containing dextromethorphan hydrobromide (DXT) and menthol (MNT). The first was a green HPTLC method which uses a mobile phase of methanol-ammonia (10:0.1, v/v). The densitometric measurements of the spots which were retained at 0.28±0.01 for DXT and 0.76±0.02 for MNT was done at 210nm. The other method was RP-HPLC method with stability indicating merits at which a mixture of 20mM phosphate buffer pH 3 and acetonitrile as mobile phase in isocratic mode was used. The cited drugs were resolved in RP-HPLC method using isocratic elution using 20mM phosphate buffer: acetonitrile (65:35 v/v) with retention times of 2.21 and 3.47min for MNT and DXT, respectively and quantified using 215nm. Both methods were entirely validated and both methods were successfully able to analyze both drugs in presence of lozenges inactive ingredients. HPLC method had the advantage of being stability indicating at which resolution of the drugs from their forced degradation products was successfully attained. For HPTLC method, both drugs showed reasonable RF values when compared to rapidly eluted MNT in RP-HPLC; also it was more environmentally friendly than RP-HPLC as it used solvents which are less toxic and greener.

Ectoine lozenges in the treatment of acute viral pharyngitis: a prospective, active-controlled clinical study.

PURPOSE: Acute pharyngitis is an uncomfortable disorder mostly caused by viruses and for which antibiotics are unwarranted. This study compared lozenges containing ectoine, a natural extremolyte, with hyaluronic acid lozenges and hypertonic saline gargle for symptomatic treatment of acute viral pharyngitis. METHODS: This prospective, controlled clinical study, recruited 90 patients with moderate-to-severe pharyngitis symptoms who chose to use either ectoine (n = 35), hyaluronic acid (n = 35), or saline gargle (n = 20). Patients applied their 7-day treatment from the inclusion visit (V1) until the end-of-study visit (V2). Patients' pharyngitis symptoms, general health, general treatment effectiveness and tolerability, and patient compliance were assessed by investigators and patients. RESULTS: The sum score for three primary symptoms (pain on swallowing, urge to cough, and hoarseness) decreased by 79.5% (ectoine), 72.2% (hyaluronic acid), and 44.8% (saline gargle). Both lozenges were significantly superior to saline gargle (P < 0.05). Regarding general health improvement, ectoine was significantly superior to saline gargle (72.5% vs. 45.2%, P < 0.05), but hyaluronic acid (63.3%) was not. At V2, 65.7% of patients receiving ectoine reported "very good" general health vs. 48.6% of those receiving hyaluronic acid and 20.0% using saline gargle. Ectoine was significantly superior (P < 0.05) to both hyaluronic acid and saline gargle in terms of tolerability and patient compliance. No patients taking ectoine reported unpleasant sensations while applying their treatment, whereas almost half of patients using hyaluronic acid lozenges and saline gargle did. CONCLUSION: Treatment with ectoine lozenges significantly relieves moderate-to-severe symptoms of acute viral pharyngitis and is more effective and tolerable than treatments with hyaluronic acid lozenges and hypertonic saline gargle.

Duration of the common cold and similar continuous outcomes should be analyzed on the relative scale: a case study of two zinc lozenge trials.

BACKGROUND: The relative scale has been used for decades in analysing binary data in epidemiology. In contrast, there has been a long tradition of carrying out meta-analyses of continuous outcomes on the absolute, original measurement, scale. The biological rationale for using the relative scale in the analysis of binary outcomes is that it adjusts for baseline variations; however, similar baseline variations can occur in continuous outcomes and relative effect scale may therefore be often useful also for continuous outcomes. The aim of this study was to determine whether the relative scale is more consistent with empirical data on treating the common cold than the absolute scale. METHODS: Individual patient data was available for 2 randomized trials on zinc lozenges for the treatment of the common cold. Mossad (Ann Intern Med 125:81-8, 1996) found 4.0 days and 43% reduction, and Petrus (Curr Ther Res 59:595-607, 1998) found 1.77 days and 25% reduction, in the duration of colds. In both trials, variance in the placebo group was significantly greater than in the zinc lozenge group. The effect estimates were applied to the common cold distributions of the placebo groups, and the resulting distributions were compared with the actual zinc lozenge group distributions. RESULTS: When the absolute effect estimates, 4.0 and 1.77 days, were applied to the placebo group common cold distributions, negative and zero (i.e., impossible) cold durations were predicted, and the high level variance remained. In contrast, when the relative effect estimates, 43 and 25%, were applied, impossible common cold durations were not predicted in the placebo groups, and the cold distributions became similar to those of the zinc lozenge groups. CONCLUSIONS: For some continuous outcomes, such as the duration of illness and the duration of hospital stay, the relative scale leads to a more informative statistical analysis and more effective communication of the study findings. The transformation of continuous data to the relative scale is simple with a spreadsheet program, after which the relative scale data can be analysed using standard meta-analysis software. The option for the analysis of relative effects of continuous outcomes directly from the original data should be implemented in standard meta-analysis programs.

Fluoride/vitamin D tablet supplementation in infants-effects on dental health after 10 years.

OBJECTIVE: We examined whether fluoride/vitamin D supplementation in the first year of life is associated with caries or molar incisor hypomineralization (MIH) at 10 years of age. METHODS: The study population consisted of 406 children for whom information on fluoride/vitamin D supplementation during the first year of life was available. Dental examination at the age of 10 included caries and MIH registration. The results of logistic regression models were adjusted for gender, age, BMI, parental education, and equivalent income. RESULTS: Children receiving supplementation during the entire first year of life had a significantly lower probability of having caries-related restorations in primary teeth in comparison to those who received supplementation for less than 6 months (fluoride supplementation: odds ratio (OR) for d3-4mfs 2.47 (1.32-4.63), for fs 2.70 (1.43-5.10); vitamin D supplementation: OR for d3-4mfs 2.08 (1.00-4.32), fs 2.50 (1.19-5.25)). The majority of logistic regression analyses indicated no association between supplementation and MIH. CONCLUSIONS: It was found a consistent significant caries-preventive effect in the primary dentition of children who received fluoride (256/372)/vitamin D supplementation (274/376) in all 12 months over the first year of life; no effects were observed for permanent dentition. The high parental interest in supplementation is linked to an imbalance of the study groups. Furthermore, tooth brushing frequency, use of fluoride toothpastes and/or other oral hygiene products were not recorded during the observation period which may also confound the results. CLINICAL RELEVANCE: Fluoride/vitamin D supplementation can be used in children for preventing caries in the primary dentition.

Nystatin and lidocaine pastilles for the local treatment of oral mucositis.

Oral mucositis (OM) is a common adverse reaction to radiotherapy and chemotherapy in oncology. Its treatment requires oral formulations that enhance therapy compliance, improve administration and ensure drug effectiveness. Solid dosage forms that act by slow dissolution, such as pastilles, are an effective alternative to mouthwashes, for their versatility, ease of administration and extended residence time in the oral cavity. The present work describes the development and stability studies of an innovative formulation of nystatin and lidocaine pastilles for the treatment of oral mucositis. Full pharmaceutical quality testing was carried out, including disintegration and dissolution testing, texture profile analysis, grittiness and an antifungal activity testing. A soft pastille formulation containing 0.25% lidocaine and 78,000 IU nystatin was obtained, presenting suitable pharmaceutical characteristics, as a disintegration time of 17 ± 2 min, dissolution rate and microbiological and physicochemical for 30 days when stored at 2-8 °C under light protection. Palatability was also evaluated, being well accepted by a panel of 38 healthy volunteers. This formulation allows an accurate drug dosing by the prescriber, while enabling the patients to control the retention time of the drugs in the oral cavity and consequently manage their pain treatment.

Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial.

The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p < 0.05). Treatment with the spray resulted in significantly greater reduction of cervical lymph node swelling (p < 0.05), ∆ spray = 0.44 ± 0.62, ∆ lozenges = 0.21 ± 0.62. The lozenges showed some advantage in relieving cough, ∆ lozenges = 0.62 ± 0.94 versus ∆ spray = 0.44 ± 0.85. Both patients and investigators rated the tolerability of both medical devices as "good" to "very good". Adverse events of mild to moderate severity were either possibly related or not related to the medical devices used. No serious adverse events occurred. Taken together, while the tolerability was consistent in both treatment groups, the ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis.

Probiotic supplements and debridement of peri-implant mucositis: a randomized controlled trial.

OBJECTIVE: The aim of this double-blind randomized placebo-controlled trial was to evaluate the effects of probiotic supplements in adjunct to conventional management of peri-implant mucositis. MATERIALS AND METHODS: Forty-nine adult patients with peri-implant mucositis were consecutively recruited after informed consent. After initial mechanical debridement and oral hygiene instructions, the patients received a topical oil application (active or placebo) followed by twice-daily intake of lozenges (active or placebo) for 3 months. The active products contained a mix of two strains of Lactobacillus reuteri. Patients were clinically monitored and sampled at baseline and after 1, 2, 4, 12 and 26 weeks. The clinical end-points were pocket-probing depth (PPD), plaque index (PI) and bleeding on probing (BOP). In addition, the subgingival microbiota was processed with checkerboard DNA-DNA hybridization and samples of gingival crevicular fluid (GCF) were analyzed for selected cytokines with the aid of multiplex immunoassays. RESULTS: After 4 and 12 weeks, all clinical parameters were improved in both the test and the placebo group. PPD and BOP were significantly reduced compared with baseline (p < 0.05), but no significant differences were displayed between the groups. The clinical improvements persisted 3 months after the intervention. No major alterations of the subgingival microflora were disclosed and the levels of inflammatory mediators in GCF did not differ between the groups. CONCLUSIONS: Mechanical debridement and oral hygiene reinforcement resulted in clinical improvement of peri-implant mucositis and a reduction in cytokine levels. Probiotic supplements did not provide added benefit to placebo.

Does early establishment of favorable oral health behavior influence caries experience at age 5 years?

OBJECTIVE: The purpose was to study associations between tooth brushing frequency, use of fluoride lozenges and consumption of sugary drinks at 1.5 years of age and having caries experience at 5 years of age. METHODS: This study was based on data from the Norwegian Mother and Child Cohort Study conducted by the Norwegian Institute of Public Health and by the Public Dental Services. A total of 1095 children were followed from pregnancy to the age of 5 years. Questionnaires regarding oral health behavior were completed by the parents at 1.5 and 5 years of age. Clinical and radiographic examination of the children was performed at the age of 5 years. RESULTS: In multiple logistic regression, having caries experience at 5 years of age was associated with; at 1.5 years of age having the teeth brushed less than twice daily (OR = 2.1, CI = 1.3-3.6) and being offered sugary drinks at least once a week (OR = 1.8, CI = 1.1-2.9) when controlled for family characteristics and oral health behavior at 5 years of age. CONCLUSIONS: Tooth brushing frequency and consumption of sugary drinks in early childhood were related to caries development during pre-school age, independent of family characteristics and oral health behavior at 5 years of age. The results indicate that early established habits regarding tooth brushing and consumption of sugary drinks have long-term effects on caries development. Parents encountering difficulties in establishing favorable oral health behavior in children's first years of life should receive special attention from health personnel.

Effect of Liquorice Candies on Remineralization of Initial Enamel Carious Lesion.

Background: Glycyrrhiza glabra (G. glabra), known as liquorice root is one such herbal remedy that has been shown to have immense potential in the treatment of orofacial diseases. Aim: To evaluate the remineralizing potential of liquorice extract on initial enamel carious lesions. Materials and methods: An in vitro and in vivo study was conducted, wherein the sound-extracted human premolars were sectioned longitudinally and into enamel blocks of size 4 × 4 mm. Enamel blocks were demineralized to produce artificial carious lesions. In vitro study, the demineralized enamel block was exposed to artificial saliva for 5 minutes and artificial saliva containing liquorice for 4 minutes 14 times in a sequential manner. An in vivo study was carried out on six volunteers aged between 6 and 12 years. The demineralized enamel block was inserted into the 5 × 5 mm window created on the full palatal coverage appliance. Patients were given commercially available liquorice candies (Ricola) to consume for 7 days twice daily. The remineralization potential of liquorice on demineralized enamel block was assessed using confocal microscopy analysis. Results: Liquorice extract containing candies showed visual remineralization of the demineralized area on the enamel surface through confocal images. Conclusion: Liquorice extract possesses remineralizing potential with its other medicinal properties. . How to cite this article: Pooja HR, Nagar P, Mascarenhas AN, et al. Effect of Liquorice Candies on Remineralization of Initial Enamel Carious Lesion. Int J Clin Pediatr Dent 2023;16(S-1):S33-S38.

Propolis as a Cariostatic Agent in Lozenges and Impact of Storage Conditions on the Stability of Propolis.

Propolis is known as a source of compounds with strong antibacterial activity. Due to the antibacterial effect against streptococci of the oral cavity, it seems to be a useful agent in decreasing the accumulation of dental plaque. It is rich in polyphenols which are responsible for a beneficial impact on the oral microbiota and antibacterial effect. The aim of the study was to evaluate the antibacterial effect of Polish propolis against cariogenic bacteria. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) were determined on cariogenic streptococci related to the occurrence of dental caries. Lozenges based on xylitol, glycerin, gelatin, water, and ethanol extract of propolis (EEP) were prepared. The effect of prepared lozenges on cariogenic bacteria was assessed. Propolis was compared to chlorhexidine which is used in dentistry as the gold standard. In addition, the prepared propolis formulation was stored under stress conditions to assess the influence of physical conditions (i.e., temperature, relative humidity, and UV radiation). In the experiment, thermal analyses were also performed to evaluate the compatibility of propolis with the substrate used to create the base of lozenges. The observed antibacterial effect of propolis and prepared lozenges with EEP may suggest directing subsequent research on prophylactic and therapeutic properties decreasing the accumulation of dental plaque. Therefore, it is worth highlighting that propolis may play an important role in the management of dental health and bring advantages in preventing periodontal diseases and caries as well as dental plaque. The colorimetric analyses carried out in the CIE L*a*b* system, microscopic examinations, and TGA/DTG/c-DTA measurements indicate the unfavorable effect of the tested storage conditions on the lozenges with propolis. This fact is particularly evident for lozenges stored under stress conditions, i.e., 40 °C/75% RH/14 days, and lozenges exposed to UVA radiation for 60 min. In addition, the obtained thermograms of the tested samples indicate the thermal compatibility of the ingredients used to create the formulation of lozenges.

The Efficacy of Nitric Oxide-Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patients of African American and Hispanic Origin.

BACKGROUND: The study was initiated in 2020 to test the efficacy of a nitric oxide-generating lozenge (NOL) in outpatients with newly diagnosed COVID-19 to mitigate disease severity. The study enrolled high-risk patients, African American and Latino. METHODS: This was a randomized, double-blinded, prospective, placebo-controlled trial. The primary endpoint was hospitalization, intensive care unit admission, intubation, dialysis, and death. The secondary endpoints were time to symptom resolution and the effect on oxygen saturation. Patients ages 50-85 years with recent COVID-19 diagnosis with at least one risk factor were recruited. Patients were randomized to either active treatment or placebo using block randomization. Blood pressure and oxygen saturation (SpO2) was measured prior to and after the first dose and each morning thereafter. RESULTS: A total of 840 patients was planned, half in each of the lozenge and placebo groups. An interim review of data was prespecified. Of 524 patients, the composite endpoint occurred in 6 patients, 3 (1.1%) in each group. The time to symptom resolution was 1 day shorter on active treatment (8.7 ± 6.6 vs 9.8 ± 6.8 days) (P = .3). There was no change in SpO2 on placebo (0.0 ± 2.0%) and no significant change on treatment (0.14 ± 0.9%), P = .3. All events occurred in the first year (2020). CONCLUSIONS: This study did not find a benefit of NOL therapy in COVID-19 patients and was terminated for futility. NOL treatment did not reduce mortality, hospitalization, intubation, or a reduction in symptoms duration. The study did find the NO lozenges were well tolerated in high-risk patients, without reported side effects.

Development and Optimization of a Novel Lozenge Containing a Metronidazole-Peppermint Oil-Tranexamic Acid Self-Nanoemulsified Delivery System to Be Used after Dental Extraction: In Vitro Evaluation and In Vivo Appraisal.

In-depth studies on essential oil-based nanoemulsions (NEs) have centered on a variety of oral health issues. NEs improve the delivery of nonpolar active agents to sites and thereby boost the dissolution and distribution of the agents. Metronidazole-peppermint oil-tranexamic acid self-nanoemulsifying drug delivery systems (MZ-PO-TX-SNEDDS) were created and loaded into novel lozenges to act as antifungal, hemostatic, antimicrobial, and analgesic dosage forms after dental extractions. The design-of-experiments approach was used in creating them. To generate the NEs, different concentrations of MZ-PO (240, 180, and 120 mg), 2% TX (600, 450, and 300 mg), and Smix1:1 (600, 400, and 200 mg) were used. The ideal formulation had serum levels of 1530 U/mL of interleukin-6, a minimal inhibitory concentration against bacteria of 1.5 µg/mL, a droplet size of 96 nm, and a blood coagulation time of 16.5 min. Moreover, the produced NE offered better MZ release. The adopted design was used to produce the ideal formulation; it contained 240 mg of MZ-PO, 600 mg of 2% TX, and 600 mg of Smix1:1. It was incorporated into lozenges with acceptable characteristics and an improved capability for drug release. These lozenges had reasonable coagulation times, IL-6 serum levels, and MIC values. All of these characteristics are desirable for managing symptoms following tooth extractions. Therefore, these lozenges loaded with MZ-PO-TX-SNEDDs might be considered a beneficial paradigm for relieving complications encountered after tooth extractions.

Effectiveness of the Lorodent Probiotic Lozenge in Reducing Plaque and Streptococcus mutans Levels in Orthodontic Patients: A Double-Blind Randomized Control Trial.

Orthodontic patients are at a significant risk for oral diseases due to increased plaque accumulation and oral bacterial dysbiosis. We aimed to determine the efficacy of the commercially available Lorodent Probiotic Complex at reducing plaque accumulation and Streptococcus mutans bacterial levels in adolescent orthodontic patients. Sixty adolescents undergoing fixed orthodontic treatment for a minimum of 6 months were recruited in a randomized, double-blind, parallel-group, placebo-controlled trial. They received either Lorodent probiotic lozenge (intervention, n = 30) or placebo lozenge (control, n = 30) orally every day for a 28-day administration period. Participants were assessed at four appointments (T1-T4) over a total of 56 days. Compliance and lozenge satisfaction were monitored. Saliva samples and supragingival plaques were collected for evaluation of S. mutans levels. Clinical assessment using a Plaque Index (PI) was used. Compliance with lozenge intake of all participants was over 90%. There was no significant change in the PI and composite PI scores in both placebo and probiotic groups at each time frame (all p > 0.05) or the relative S. mutans DNA levels in the saliva and plaque between the probiotic and placebo groups. The findings of high compliance and satisfaction with the probiotic lozenges combined with the study's rigorous design offer a baseline for subsequent testing of further potential probiotics (of varying formulations, concentrations), especially in adolescents.