Dental applications of Punica granatum L. in the treatment of gingivitis: A review of ethnomedicinal uses, randomized clinical trials, and antibacterial potential against Porphyromonas gingivalis.

ETHNOPHARMACOLOGICAL RELEVANCE: Mouthwashes based on medicinal plants have demonstrated benefits in controlling plaque and inflammation, acting positively on the oral hygiene of patients with gingivitis. In traditional medicine, Punica granatum L. has been used to treat oral diseases in countries in Europe, Asia, North America, and Africa. AIM OF THE STUDY: The present study aimed to conduct a comprehensive review on the dental applications of Punica granatum L. for the treatment of gingivitis, including ethnomedicinal uses, analysis of randomized clinical trials, antibacterial activity against Porphyromonas gingivalis, mechanisms of action of phytochemicals isolated from this plant, and preclinical toxicity. MATERIALS AND METHODS: The literature was retrieved from Google Scholar, PubMed®, SciELO, and ScienceDirect®, since the first report published on the topic in 2001 until March 2024. RESULTS: Several clinical trials have demonstrated that mouthwashes containing P. granatum have equal or better efficacy than chlorhexidine in treating patients with gingivitis, confirming the indications for use of this plant by traditional communities. However, reports on the in vitro antibacterial activity of extracts from the fruits of this plant have not shown clinical relevance against the pathogen P. gingivalis. The ellagitannin punicalagin isolated from P. granatum has shown potential against several strains of Gram-positive and Gram-negative bacteria, but, to date, this compound has not yet been tested against P. gingivalis. It is likely that the mechanisms of action of flavonoids, such as quercetin, are involved in the inhibition of the activities of the RgpA, RgpB, and Kgp proteases of P. gingivalis. CONCLUSIONS: In summary, natural products obtained from P. granatum do not present toxic side effects and can be considered as possible substitutes of commercial products recommended for the treatment of gingivitis and other oral diseases.

The Clinical Effect of a Propolis and Mangosteen Extract Complex in Subjects with Gingivitis: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial.

This study investigated the efficacy and safety of a propolis-mangosteen extract complex (PMEC) on gingival health in patients with gingivitis and incipient periodontitis. A multicentered, randomized, double-blind, placebo-controlled trial involving 104 subjects receiving either PMEC or placebo for eight weeks was conducted. The primary focus was on the changes in inflammatory biomarkers from gingival crevicular fluid (GCF), with clinical parameters as secondary outcomes. The results revealed that the PMEC group showed a significantly reduced expression of all measured GCF biomarkers compared to the placebo group (p < 0.0001) at 8 weeks, including substantial reductions in IL-1ß, PGE2, MMP-8, and MMP-9 levels compared to the baseline. While clinical parameters trended towards improvement in both groups, the intergroup differences were not statistically significant. No significant adverse events were reported, indicating a favorable safety profile. These findings suggest that PMEC consumption can attenuate gingival inflammation and mitigate periodontal tissue destruction by modulating key inflammatory mediators in gingival tissue. Although PMEC shows promise as a potential adjunctive therapy for supporting gingival health, the discrepancy between biomarker improvements and clinical outcomes warrants further investigation to fully elucidate its therapeutic potential in periodontal health management.

Comparative anti-plaque and anti-gingivitis efficiency of Triphala versus chlorhexidine mouthwashes in children: a systematic review and meta-analysis.

The aim of this systematic review is to comparatively evaluate the Triphala and chlorhexidine mouthwashes efficacies in decreasing plaque formation and gingivitis in children. With a priori-set inclusion and exclusion criteria's and relevant MeSH terms, the PubMed, Cochrane and Ovid SP were scrutinized from the year 1980 to April 2023 for prospective articles. Outcomes evaluated were plaque formation and gingivitis through Plaque index and Gingival index. Five studies were finally included and were analyzed qualitatively and quantitatively. Meta-analysis, was performed using a random effects model. Plaque index (PI) and Gingival Index (GI). There was no significant difference between reduction in the gingivitis and plaque accumulation between Triphala and chlorhexidine mouthwash groups in children (p value 0.83, 0.96).

Antibacterial and oral tissue effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride.

OBJECTIVES: Reflecting the need for an effective support for the daily oral hygiene routine of patients experiencing (symptoms of) gum inflammation, a new mouthwash has been developed containing an amine + zinc lactate + fluoride system. The in vitro efficacy of this product was assessed using traditional laboratory methods, as well as novel experimentation. MATERIALS AND METHODS: This mouthwash has been evaluated in a series of laboratory tests including two short interval kill tests (SIKTs), a 12-h (longer term) biofilm regrowth assay, a plaque glycolysis assay, and an aerobic, repeated exposure biofilm model, as well as tests for soft tissue uptake and LPS neutralization. RESULTS: Several laboratory studies demonstrate that a mouthwash containing an amine + zinc lactate + fluoride system provides short-term and long-term antibacterial activity. While the immediate efficacy of this formula has been shown to be driven by the presence of the amine, zinc lactate provides a long-term antibacterial effect, as well as is able to inhibit bacterial metabolism. CONCLUSIONS: This research provides the basis for understanding the mode of action of this new mouthwash formulation and explains the previously observed clinical efficacy of this formula against plaque and gingivitis.

Effectiveness of herbal oral care products in reducing dental plaque and gingivitis: an overview of systematic reviews.

Introduction: Numerous clinical trials and systematic reviews have investigated the effectiveness of both herbal and conventional oral care approaches to reducing plaque and gingivitis. However, their findings vary and are inconsistent. Thus, the objective of this umbrella review is to compile data from systematic reviews and provide an overview of the effects of herbal oral care products on tooth plaque and gingivitis. Methods: A comprehensive search of the literature was performed in 6 databases for systematic reviews with or without meta-analyses, published up to 30 May 2023, without any language restrictions. Only clinical trials comparing herbal oral care products (in the form of mouthrinse or toothpaste) against standard oral care products or placebo were considered. Results: Some herbal oral care products, particularly in the form of mouthrinses, have a similar level of positive effect on plaque and gingivitis reduction and, thus, can be used as an adjunct to traditional dentifrices. However, the shorter duration of trials (<4 weeks) and reported publication bias in the clinical trials mean that these findings must be interpreted with caution. Conclusion: To accurately determine the impact of various herbal extracts on periodontal health, well-designed, long-term, and controlled trials that adhere to standardized protocols must be carried out.

Introduction: On a étudié l'efficacité d'approches de soins buccodentaires classiques et à base de plantes pour lutter contre la plaque dentaire et la gingivite dans le cadre de nombreux essais cliniques et revues systématiques. Toutefois, leurs conclusions ont été variables et incohérentes. Cette revue générale vise donc à compiler des données issues de revues systématiques et de présenter un aperçu des effets des produits de soins buccodentaires à base de plantes sur la plaque dentaire et la gingivite. Méthodes: On a procédé à une recherche documentaire exhaustive dans 6 bases de données pour effectuer des revues systématiques, avec ou sans méta-analyses, sans aucune restriction relative à la langue de l'étude, publiées avant le 30 mai 2023. Seuls des essais cliniques comparant des produits de soins buccodentaires à base de plantes (sous forme de rincebouche ou de dentifrice) à des produits de soins buccodentaires classiques ou à des placebos ont été envisagés. Résultats: Quelques produits de soins buccodentaires à base de plantes, en particulier les rince-bouches de ce type, ont des effets positifs comparables en matière de réduction de la plaque et de la gingivite et peuvent donc être utilisés en complément des dentifrices ordinaires. Toutefois, ces résultats doivent être interprétés avec prudence du fait de la durée relativement courte des essais (moins de 4 semaines) et du biais de publication signalé dans les essais cliniques. Conclusion: Pour déterminer avec précision les effets de divers extraits de plantes sur la santé parodontale, il est nécessaire d'avoir recours à des essais bien conçus, à long terme et contrôlés, qui respectent des protocoles normalisés.

Brazilin cream from Caesalpinia sappan inhibit periodontal disease: in vivo study.

Background: Gingivitis is an inflammation of the gums that is the initial cause of the development of periodontal disease by the activity of Nuclear Factor-kappa B (NF-κB), Interleukin-1ß (IL-1ß), Interleukin-6 (IL-6), p38, and Tumor Necrosis Factor-α (TNF-α). Unaddressed chronic inflammation can lead to persistent disturbances in other parts of the body. Brazilin is a naturally occurring plant chemical that may have antibacterial and anti-inflammatory effects. Treatment based on the natural plant compound, brazilin, is developed in the form of a topical cream for easy application. Objective: The aim is to develop the natural compound brazilin in the form of a topical cream as an anti-inflammatory agent to reduce NF-κB expression through Imunohistochemistry (IHC) methods, and the expression of pro-inflammatory genes IL-1ß, IL-6, p38, and TNF-α. Methods: Male Sprague-Dawley rats were induced with gingivitis using P. gingivalis bacteria. The observed groups included rats treated with a single application of brazilin cream and rats treated with two applications of brazilin cream. The treatment was administered for 15 days. On days 3, 6, 9, 12, and 15, anatomical wound observations and wound histology using hematoxylin-eosin and Masson's Trichrome staining were performed. NF-κB protein expression was analyzed using the IHC method. Gingival inflammation gene expression of NF-κB, IL-1ß, IL-6, p38, and TNF-α was measured using q-RTPCR. Results: Single and double applications of brazilin cream increased angiogenesis and decreased NF-κB protein expression, in addition to the IL-1ß, IL-6, p38, and TNF-α gene expressions. Conclusion: In a rat gingivitis model, Brazilin cream may function as an anti-inflammatory agent in the gingival tissue.

Evaluating the Therapeutic Properties of Natural Products in Orthodontic and Surgical Treatment of Dentofacial Deformities: A Systematic Review of Clinical Trials.

The use of natural products as alternatives to traditional pharmacological treatments in orthodontics is gaining interest due to their anti-inflammatory, antibacterial, and antioxidant properties. This systematic review synthesizes evidence from clinical trials to evaluate the efficacy of natural products in reducing inflammation and bacterial presence in orthodontic and orthognathic treatment settings. The database search was conducted across PubMed, Scopus, and Embase up to January 2024. The review focused on randomized controlled trials only. The selected studies centered on the anti-inflammatory, antibacterial, and antioxidant effects of natural products, adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines for data extraction. Nine studies, totaling 358 participants, were included. Significant findings demonstrated a reduction in gingival inflammation by over 40% with the use of Aloe vera compared to chlorhexidine. Another study noted a decrease in bleeding on probing by 13.6 points in the treatment group over placebo. Additionally, honey showed a rapid modulation of plaque pH and significantly reduced bacterial counts of Streptococcus mutans. Furthermore, the use of resveratrol emulgel was linked to substantial improvements in gingival health, with a reduction in the gingival index and probing pocket depth. The results indicate that natural products can significantly enhance orthodontic treatment outcomes by reducing inflammation and bacterial levels. These products offer effective alternatives to traditional treatments and show potential for integration into routine orthodontic care protocols. Further research is encouraged to standardize application methods and dosages to maximize clinical benefits and patient satisfaction.

Clinical effect of equol supplementation in the treatment of desquamative gingivitis with 1-year follow-up.

PURPOSE: Desquamative gingivitis (DG) is characterized by desquamative erosion, edematous erythema, and vesicle formation on the gingiva. Because of its prevalence in women during the pre- and postmenopausal period, its potential association with female hormones has been suggested. Equol is a soy isoflavone metabolite with a chemical structure similar to estrogen. Scientific evidence suggests that equol helps in alleviating menopausal symptoms. This study evaluated the clinical effect of a 12-month equol supplementation as a substitute for estrogen to alleviate DG symptoms. METHODS: The study enrolled 16 women with DG who regularly visited Nihon University School of Dentistry Dental Hospital. Urinary equol levels, periodontal tissue examination, O'Leary's plaque control record, stimulated saliva flow rate, and gingival pain-related questionnaires were evaluated before and after the 12-month daily intake of 10 mg equol supplement. RESULTS: Equol supplementation led to a statistically significant improvement in bleeding on probing, visual findings, and reductions in the frequency and severity of gingival pain. CONCLUSION: Urinary equol testing and equol supplementation may be novel treatment options for female patients with DG.

Clinical Effect of Thioglycosides Extracted from White Mustard on Dental Plaque and Gingivitis: Randomized, Single-Blinded Clinical Trial.

The antibacterial and anti-inflammatory effect of thioglycosides has already been established. This study investigates the effects of thioglycosides extracted from white mustard, specifically the "Bamberka" variety, in the context of oral hygiene. The aim of the study is to clarify an evidence-based link between the documented antibacterial and anti-inflammatory effects attributed to thioglycosides and their practical application in oral care. A randomized, single-blinded (patient-blinded) clinical study was performed on 66 patients using mustard-based toothpaste for oral hygiene. The patients were examined at baseline and after 6 and 12 months. The values of the Approximal Plaque Index (API), the Plaque Index (PI), and Bleeding on probing (BOP) were taken into consideration. The results show a significant reduction in plaque accumulation, especially after 6 months of using mustard-based toothpaste in all examined parameters. This suggests that thioglycosides from mustard contribute to a considerable decrease in dental plaque accumulation, confirming their potential in natural oral care solutions, which is indicated in the main conclusions or interpretations.

Comparative effectiveness of Propolis with chlorhexidine mouthwash on gingivitis - a randomized controlled clinical study.

BACKGROUND: To assess and compare the effectiveness of propolis mouthwash with chlorhexidine mouthwash in the reduction of plaque and gingivitis. METHODS: A single centre, latin-square cross-over, double masked, randomized controlled clinical trial was conducted on 45 chronic generalized gingivitis subjects who were chosen from the dental clinic of MAHSA University, Malaysia. A total of 45 subjects were randomly assigned into one of the three different groups (n = 15 each) using a computer-generated random allocation sequence: Group A Propolis mouthwash; Group B Chlorhexidine mouthwash; and Group C Placebo mouthwash. Supragingival plaque and gingival inflammation were assessed by full mouth Plaque index (PI) and gingival index (GI) at baseline and after 21 days. The study was divided into three phases, each phase lasted for 21 days separated by a washout period of 15 days in between them. Groups A, B and C were treated with 0.2% Propolis, Chlorhexidine, and Placebo mouthwash, respectively, in phase I. The study subjects were instructed to use the assigned mouthwash twice daily for 1 min for 21 days. On day 22nd, the subjects were recalled for measurement of PI and GI. After phase I, mouthwash was crossed over as dictated by the Latin square design in phase II and III. RESULTS: At baseline, intergroup comparison revealed no statistically significant difference between Groups A, B and C (p > 0.05). On day 21, one-way ANOVA revealed statistically significant difference between the three groups for PI (p < 0.001) and GI (p < 0.001). Bonferroni post-hoc test showed statistically significant difference between Propolis and Chlorhexidine mouthwash (P < 0.001), with higher reduction in the mean plaque and gingival scores in propolis group compared to chlorhexidine and placebo groups. CONCLUSIONS: Propolis mouthwash demonstrated significant improvement in gingival health and plaque reduction. Thus, it could be used as an effective herbal mouthwash alternative to chlorhexidine mouthwash. TRIAL REGISTRATION: The trial was retrospectively registered on 25/07/2019 at clinicaltrials.gov and its identifier is NCT04032548.

Comparative evaluation of the efficacy of probiotic, Aloe vera, povidine-iodine, and chlorhexidine mouthwashes in the treatment of gingival inflammation: A randomized controlled trial.

BACKGROUND: Chemical plaque control with mouthwashes as an adjunct to mechanical plaque control with a toothbrush and dental floss has been considered an effective method for controlling gingivitis. The anti-inflammatory effects of chemical plaque control benefit the oral tissues by reducing inflammation and bleeding. OBJECTIVES: The aim of the present study was to evaluate and compare the clinical efficacy of probiotic, Aloe vera, povidine-iodine, and chlorhexidine (CHX) mouthwashes in treating gingivitis patients by assessing changes in their clinical parameters. MATERIAL AND METHODS: This prospective study was conducted on 40 patients from our outpatient department, divided into 4 groups of 10 patients each: probiotic mouthwash group (group 1); herbal (Aloe vera) mouthwash group (group 2); povidone-iodine mouthwash group (group 3); and CHX mouthwash group (group 4). All participants were provided with the same type of manual toothbrush, the Pepsodent® toothpaste and a respective mouthwash for twice-daily use until the end of a 28-day observation period. Clinical parameters, such as the marginal plaque index (MPI) and bleeding on interdental brushing (BOIB), were recorded at baseline, and on the 14th and 28th day of the study period. RESULTS: All groups showed a significant decrease in the MPI and BOIB scores. The results were similar in patients who used a probiotic mouthwash and those who used a CHX mouthwash. A comparable change in the mean scores was observed among the herbal and povidone-iodine groups from baseline to day 28. CONCLUSIONS: In the treatment of chronic gingivitis patients,a probiotic mouthwash was nearly as effective as CHX in reducing the plaque and bleeding scores. It showed better results in all clinical parameters than herbal and povidone-iodine mouthwashes. Using a mouthwash along with routine tooth brushing can help in treating gingivitis and slow the progression of the periodontal disease.

The impact of Lacticaseibacillus paracasei GMNL-143 toothpaste on gingivitis and oral microbiota in adults: a randomized, double-blind, crossover, placebo-controlled trial.

BACKGROUND: This study examines the oral health benefits of heat-killed Lacticaseibacillus paracasei GMNL-143, particularly its potential in oral microbiota alterations and gingivitis improvement. METHODS: We assessed GMNL-143's in vitro interactions with oral pathogens and its ability to prevent pathogen adherence to gingival cells. A randomized, double-blind, crossover clinical trial was performed on gingivitis patients using GMNL-143 toothpaste or placebo for four weeks, followed by a crossover after a washout. RESULTS: GMNL-143 showed coaggregation with oral pathogens in vitro, linked to its surface layer protein. In patients, GMNL-143 toothpaste lowered the gingival index and reduced Streptococcus mutans in crevicular fluid. A positive relationship was found between Aggregatibacter actinomycetemcomitans and gingival index changes, and a negative one between Campylobacter and gingival index changes in plaque. CONCLUSION: GMNL-143 toothpaste may shift oral bacterial composition towards a healthier state, suggesting its potential in managing mild to moderate gingivitis. TRIAL REGISTRATION: ID NCT04190485 ( https://clinicaltrials.gov/ ); 09/12/2019, retrospective registration.

Efficacy and Tolerability of a Scutellaria lateriflora L. and Cistus × incanus L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Preclinical studies have shown that the combination of Cistus × incanus L. and Scutellaria lateriflora L. extracts exerts beneficial effects on oral health against gingivitis. Thus, this study aimed to assess the tolerability of a chewing gum and its efficacy on gingivitis in a double-blind, placebo-controlled clinical trial. Enrolled subjects (n = 60, 18-70 years) were randomized to receive two chewing gums or a placebo daily for 3 months. At baseline (t0) and monthly (t1, t2, and t3) timepoints, the Quantitative Gingival Bleeding Index (QGBI), the Modified Gingival Index (MGI), and the Oral Health 15 items (OH-15)] were employed to assess potential improvements in gingivitis. Pain was self-quantified via the Visual Analogue Scale (VAS), and the Clinical Global Impression Scale for Severity of illness (CGI-S) helped in evaluating the oral general conditions. This study is listed on the ISRCTN registry. At t3, the QGBI, MGI, OH-15, VAS, and CGI-S values decreased in the treated but not in the placebo group (ß = 0.6 ± 0.1, t176 = 3.680, p < 0.001; ß = 0.87 ± 0.21, t115 = 4.263, p < 0.001; ß = 5.3 ± 2.5, t172 = 2.086, p = 0.038; ß = 3.16 ± 0.51, t88 = 6.253, p < 0.001; and ß = 1.09 ± 0.32, t83 = 3.419, p < 0.001, respectively). A significant improvement in gingival health occurred after a 3-month intervention with the chewing gums containing S. lateriflora and C. incanus extracts.

Efficacy of 38% silver diamine fluoride in reducing gingival inflammation and plaque accumulation in older adults living in retirement-homes: A randomized controlled pilot trial.

OBJECTIVES: Emerging from earlier case reports the potential benefits of 38 % silver diamine fluoride (SDF) in addressing pathogenic biofilms and mitigating gingival inflammation and enlargement have sparked interest. Our study aimed to evaluate the efficacy of 38 % SDF in reducing gingival inflammation and plaque accumulation in older adults living in retirement-homes. METHODS: This 7-week randomized, controlled, double-blinded pilot trial employed a parallel assignment design. The study enrolled older adults (aged ≥65) residing in retirement homes in Dallas County, ultimately comprising a cohort of 40 participants who were evenly divided into two arms. The experimental group received SDF treatment, whereas the comparator group received a placebo. Over three consecutive weeks, both groups had solutions applied to the facial surfaces of all their teeth once per week. The primary outcomes measured the change in Löe-Silness Gingival Index (GI) and Silness-Löe Plaque Index (PI) at 7 weeks following baseline treatment. Repeated measures ANOVA was utilized to assess changes over time within each group (n = 15 each). Post-hoc paired t-tests were conducted to compare changes between week 1 and each subsequent follow-up time point (weeks 3, 5, 7), supplemented with 95 % confidence intervals for change from week 1. RESULTS: In the SDF group, within-group comparisons demonstrated significant reductions (adjusted p < .05) in GI scores within 3 weeks (-.93±.37), as opposed to week 1 (1.90±.39). Between-group comparisons unveiled reductions in both mean GI (p < .05) and PI (p < .05), indicating less gingival inflammation and plaque accumulation in the SDF group at all time points, commencing at week 3. CONCLUSIONS: This study showed that 38 % SDF was effective in reducing gingival inflammation and plaque accumulation in older adults living in retirement-homes. CLINICAL SIGNIFICANCE: Oral health in older adults is a public health concern, especially for the medically compromised or those without traditional care. Our findings offer hope for enhancing oral health quality of life by introducing a cost-effective, compliance-free, noninvasive, and accessible therapeutic. TRIAL REGISTRATION: NCT03445286.(clinicaltrials.gov).

Phytocannabinoids and gingival inflammation: Preclinical findings and a placebo-controlled double-blind randomized clinical trial with cannabidiol.

OBJECTIVE: The aim of this study was to: (1) evaluate the anti-inflammatory effects of cannabidiol (CBD) on primary cultures of human gingival fibroblasts (HGFs) and (2) to clinically monitor the effect of CBD in subjects with periodontitis. BACKGROUND: The use of phytocannabinoids is a new approach in the treatment of widely prevalent periodontal disease. MATERIALS AND METHODS: Cannabinoid receptors were analyzed by western blot and interleukin production detected using enzyme immunoassay. Activation of the Nrf2 pathway was studied via monitoring the mRNA level of heme oxygenase-1. Antimicrobial effects were determined by standard microdilution and 16S rRNA screening. In the clinical part, a placebo-control double-blind randomized study was conducted (56 days) in three groups (n = 90) using dental gel without CBD (group A) and with 1% (w/w) CBD (group B) and corresponding toothpaste (group A - no CBD, group B - with CBD) for home use to maintain oral health. Group C used dental gel containing 1% chlorhexidine digluconate (active comparator) and toothpaste without CBD. RESULTS: Human gingival fibroblasts were confirmed to express the cannabinoid receptor CB2. Lipopolysaccharide-induced cells exhibited increased production of pro-inflammatory IL-6 and IL-8, with deceasing levels upon exposure to CBD. CBD also exhibited antimicrobial activities against Porphyromonas gingivalis, with an MIC of 1.5 µg/mL. Activation of the Nrf2 pathway was also demonstrated. In the clinical part, statistically significant improvement was found for the gingival, gingival bleeding, and modified gingival indices between placebo group A and CBD group B after 56 days. CONCLUSIONS: Cannabidiol reduced inflammation and the growth of selected periodontal pathogenic bacteria. The clinical trial demonstrated a statistically significant improvement after CBD application. No adverse effects of CBD were reported by patients or observed upon clinical examination during the study. The results are a promising basis for a more comprehensive investigation of the application of non-psychotropic cannabinoids in dentistry.

Efficacy of flossing and mouth rinsing regimens on plaque and gingivitis: a randomized clinical trial.

BACKGROUND: To investigate the effects of combinations of mechanical (brushing and flossing) and chemotherapeutic regimens which included essential oils (EO) non-alcohol and alcohol-containing mouthrinses compared to brushing only in the prevention and reduction of plaque, gingivitis, and gingival bleeding. METHODS: This was a randomized, virtually supervised, examiner blind, controlled clinical trial. Following informed consent and screening, subjects (N = 270) with gingivitis were randomly assigned to one of the following regimens: (1) Brush Only (B, n = 54); (2) Brush/Rinse (EO alcohol-containing mouthrinse) (BA, n = 54); (3) Brush/Rinse (EO non-alcohol containing mouthrinse) (BZ, n = 54); (4) Brush/Floss (BF, n = 54); (5) Brush/Floss/Rinse (EO non-alcohol containing mouthrinse) (BFZ, n = 54). Unflavored waxed dental floss (REACH unflavored waxed dental floss), and fluoridated toothpaste (Colgate Cavity Protection) were used. Examinations included oral hard and soft tissue, plaque, gingivitis, gingival bleeding, probing depth and bleeding on probing. RESULTS: After 12 weeks, both BA and BZ and the BFZ group were superior in reducing interproximal plaque (30.8%, 18.2%, 16.0%, respectively), gingivitis (39.0%, 36.9%, 36.1%, respectively), and bleeding (67.8%, 73.6%, 79.8%, respectively) compared to B. The BF group did not provide significant reductions in interproximal plaque but did reduce interproximal gingivitis (5.1%, p = 0.041) at Week 4 and bleeding at Weeks 4 and 12 (34.6%, 31.4%, p < 0.001 respectively) compared to B. The BFZ group did not significantly reduce interproximal plaque, gingivitis or bleeding compared to BZ. CONCLUSIONS: This study demonstrated that the addition of EO non-alcohol containing mouthrinse to the manual toothbrushing and flossing regimen further reduces plaque, gingivitis and bleeding showing that addition of EO mouthrinses (alcohol or non-alcohol containing) to the oral hygiene regimen provides sustained reductions in plaque to help maintain gingival health after a dental prophylaxis. Dental professional recommendation of the addition of an EO non-alcohol containing mouthrinse to daily oral hygiene routines of brushing or brushing and flossing should be considered to aid supragingival plaque control and improve gingivitis prevention. STUDY REGISTRY NUMBER: NCT05600231.

Efficacy of an experimental toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride on gingivitis.

BACKGROUND: Gingivitis is driven by plaque accumulation and, if left untreated, can progress to irreversible periodontitis. For many, the mechanical action of toothbrushing does not achieve adequate plaque control. The aim of this study was to investigate whether twice-daily use of a toothpaste containing 0.2% high molecular weight (HMW) sodium hyaluronate with 67% sodium bicarbonate and 0.221% sodium fluoride (experimental toothpaste) could improve gingival health compared with a regular fluoride toothpaste (negative control). The study also assessed whether the experimental toothpaste could provide additive gingival health benefit over a toothpaste containing only 67% sodium bicarbonate and 0.221% sodium fluoride (positive control). METHODS: This was a single-center, examiner-blinded, randomized, clinical study in healthy adults with mild-to-moderate gingivitis. At baseline, after abstaining from toothbrushing for 12 h, prospective participants underwent oral soft tissue (OST) and oral hard tissue examination followed by assessments for gingival inflammation (Modified Gingival Index [MGI]), gingival bleeding (Bleeding Index [BI]), and supra-gingival plaque (Turesky Plaque Index [TPI]). Eligible participants were stratified by gender and baseline number of bleeding sites (low: <45; high: ≥45 bleeding sites). Following randomization, participants underwent prophylactic dental treatment. Participants received a full OST examination, MGI, BI and TPI assessments after 3 days, 1, 2 and 6 weeks of product use. RESULTS: In total, 110 participants were screened for study entry and all were randomized to receive one of three toothpastes (experimental: sodium hyaluronate, sodium bicarbonate, sodium fluoride; positive control: sodium bicarbonate, sodium fluoride; negative control: regular fluoride toothpaste). For all measures, significant improvements were observed in participants receiving either sodium bicarbonate-containing toothpaste (experimental or positive control) compared with the regular fluoride toothpaste (negative control) at week 6. No significant difference was observed in any assessment or visit comparing the experimental toothpaste with the positive control. CONCLUSIONS: Both the experimental and the positive control toothpastes demonstrated clinically relevant improvements in gingival health compared with a regular fluoride toothpaste (negative control). However, no additional gingival health improvement was observed for the experimental toothpaste compared with the positive control, therefore, no additional gingival health benefit can be attributed to the inclusion of sodium hyaluronate in this formulation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04737538 (04/02/2021).

Use of over-the-counter mouthwashes as an additional measure in individual oral prophylaxis on adults with plaque-induced gingivitis: a double-blind, parallel, randomized controlled trial.

BACKGROUND: Plaque-induced gingivitis is a chronic inflammatory condition characterized by complete reversibility of tissue damage once the periodontal biofilm has been disorganised. The aim of this study was to evaluate the efficacy of two commercially available mouthwashes (MWs) versus a chlorhexidine (CHX) 0.12% MW in reducing gingival bleeding (GB) in adults with plaque-induced gingivitis. METHODS: The present study was a double-blind, parallel, randomized controlled trial involving 6492 gingival sites (i.e. 39 subjects × 28 teeth × 6 sites/tooth) aged 18-75 years. During a 2-week period, subjects were randomized to receive MWs: a control CHX 0.12% MW (group C, 1818 sites); a MW test containing CHX 0.09% + Citrox®/P complex (group CX, 2628 sites); a MW test based on natural compounds (group P, 2016 sites). GB was assessed at the inclusion visit (T0) and after 2 weeks of MW use (T1). Analyses of GB were compared between groups and then restricted to subjects with bleeding sites between 10 and 30% (moderate gingivitis) or ≥ 30% (severe gingivitis) at T0. Pairwise comparisons were made between groups and logistic regression was used to identify correlates of GB (T1). RESULTS: For total bleeding site analysis, GB reduction between T0 and T1 ranged from 23% (C), 26% (CX) and 36% (P), respectively (all p < 0.05). Multiple comparison between groups showed that group C was significantly less effective (p < 0.05) than groups CX and P. Splitting the analysis, in patients with severe gingivitis (≥ 30% bleeding sites at T0), all MWs had a positive effect on GB with a reduction at T1 of 36% (C), 33% (CX) and 42% (P), respectively. While GB reduction between T0 and T1, was significant for all groups, the comparison among groups showed no significant difference between group C and CX, whereas the improvement was significant for group P. On the other hand, in adults with moderate gingivitis (< 30% bleeding sites at T0), only CX and P had a positive effect on GB reduction at T1(9% in CX and 2% in P, respectively), although the differences between the three groups were not significant. CONCLUSION: The daily use of MWs with natural components (groups P and CX) for 2 weeks should be considered positively as an adjunct to individual oral prophylaxis to reduce GB compared to the control MW containing CHX 0.12% (group C) in healthy adults with plaque-induced gingivitis. For subjects with severe gingivitis, it is advisable to first use natural MW (P) and then MW based on CHX 0.09% with natural components (CX), compared to MW with CHX 0.12% (C). For adults with moderate gingivitis, P and CX can be advisable, even if no definitive recommendations can be drawn. TRIAL REGISTRATION: ACTRN12622000215729, 07/02/2022.

Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial.

OBJECTIVES: To support the daily oral hygiene of patients experiencing gum inflammation, a new mouthwash was developed containing an amine + zinc lactate + fluoride system. In vitro and clinical efficacy was assessed using traditional methods as well as using novel site-specific and subject-specific analyses of the clinical data. MATERIALS AND METHODS: This mouthwash was evaluated in a 12-h biofilm regrowth assay against a negative control mouthwash and in a 6-month plaque and gingivitis clinical study as compared to a negative control mouthwash. Analyses of healthy versus inflamed sites, visible plaque versus non-visible plaque sites, as well as subject-level evaluations bring new perspectives to the overall performance of this mouthwash and its significance from a patient outcome perspective. RESULTS: Studies demonstrated that this new mouthwash provided long-term (12-h) antibacterial activity after single application in vitro and reduced clinically all plaque and gingivitis parameters after 3 months and 6 months of use when compared to the negative control mouthwash. Examination of site-level and subject-level data determined that this mouthwash significantly increased the number of healthy sites in the oral cavity and significantly improved the gum health of subjects in the study, as compared to the negative control mouthwash. CONCLUSIONS: In vitro and clinical research has demonstrated the antibacterial and clinical benefits of this mouthwash containing an amine compound + zinc lactate + fluoride system. CLINICAL RELEVANCE: Our subject-specific and site-specific analyses provide the dental practitioner with tools that can be used to guide patients who suffer from gingivitis toward optimal product selection and use. CLINICAL TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (reference no. NCT05821712).

Ingredients in Commercially Available Mouthwashes.

OBJECTIVES: Mouthwashes, a cornerstone of oral and dental hygiene, play a pivotal role in combating the formation of dental plaque, a leading cause of periodontal disease and dental caries. This study aimed to review the composition of mouthwashes found on retail shelves in Turkey and evaluate their prevalence and side effects, if any. METHODS: The mouthwashes examined were sourced from the 5 largest chain stores in each district of Istanbul. A comprehensive list of the constituents was meticulously recorded. The research was supported by an extensive compilation of references from scholarly databases such as Google Scholar, PubMed, and ScienceDirect. Through rigorous analysis, the relative proportions of mouthwash ingredients and components were determined. RESULTS: A total of 45 distinctive variations of mouthwashes, representing 17 prominent brands, were identified. Amongst the 116 ingredients discovered, 70 were evaluated for potential adverse effects and undesirable side effects. The aroma of the mouthwash (n = 45; 100%), as welll as their sodium fluoride (n = 28; 62.22%), sodium saccharin (n = 29; 64.44%), sorbitol (n = 21; 46.6%), and propylene glycol (n = 28; 62.22%) content were the main undesireable features. CONCLUSIONS: The limited array of mouthwashes found on store shelves poses a concern for both oral and public health. Furthermore, the intricate composition of these products, consisting of numerous ingredients with the potential for adverse effects, warrants serious attention. Both clinicians and patients should acknowledge the importance and unwarranted side effects of the compnents of the mouthwashes.