دورية أكاديمية
Pilot, open-label, randomized controlled clinical trial evaluating 4 oral hygiene regimens using a manual toothbrush, toothpaste, and mouthwash.
| العنوان: | Pilot, open-label, randomized controlled clinical trial evaluating 4 oral hygiene regimens using a manual toothbrush, toothpaste, and mouthwash. |
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| المؤلفون: | Rosu S, Benatti P, Bianco S, Barattini DF, Nobile V, Mellai M, Cattaneo D |
| المصدر: | General dentistry [Gen Dent] 2024 Jul-Aug; Vol. 72 (4), pp. 62-71. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Academy of General Dentistry Country of Publication: United States NLM ID: 7610466 Publication Model: Print Cited Medium: Internet ISSN: 0363-6771 (Print) Linking ISSN: 03636771 NLM ISO Abbreviation: Gen Dent Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, Academy of General Dentistry. |
| مواضيع طبية MeSH: | Mouthwashes*/therapeutic use , Toothpastes*/therapeutic use , Toothbrushing*/instrumentation , Oral Hygiene*/methods, Humans ; Pilot Projects ; Female ; Male ; Adult ; Middle Aged ; Prospective Studies ; Aged ; Patient Satisfaction |
| مستخلص: | In this prospective pilot study, 84 patients with a history of poor oral hygiene were enrolled in an open-label, interventional, randomized controlled clinical trial. The aim was to provide preliminary clinical data on a new line of oral hygiene products containing a prebiotic and a paraprobiotic based on Lactobacillus plantarum. The recruitment rate and patient satisfaction were analyzed to estimate resources for the future primary study, and descriptive data on rebalancing of the oral microbiota were collected. The population was divided into 5 groups based on the products assigned to the patients: 1, delicate mint toothpaste (n = 20); 2, mint toothpaste (n = 12); 3, mint mouthwash (n = 20); 4, delicate mint toothpaste, mint mouthwash, and an antimicrobial toothbrush (n = 20); and 5, continued use of their usual oral care products and routine (control group; n = 12). The study duration was 28 days. All patients tolerated the products well, and there were no adverse events. The recruitment capability and procedures allowed for a realistic estimation for the future main trial. The products did not cause any changes in tooth color. The participants in group 4, who completed the treatment consisting of delicate mint toothpaste, mint mouthwash, and an antimicrobial toothbrush, reported the greatest reduction in gingival sensitivity (P ≤ 0.000; Wilcoxon signed rank test). Analysis with the Wilcoxon signed rank test revealed that all products induced a statistically significant decrease in plaque (P ≤ 0.002) and a reduction in gingival sensitivity (delicate mint toothpaste, P ≤ 0.005; mint toothpaste, P ≤ 0.015; and mint mouthwash, P ≤ 0.015). All products were effective in stabilizing the oral microbiota. The tested products showed an optimal safety profile and a statistically significant efficacy in reducing gingival sensitivity and plaque. They also stabilized the biodiversity of the oral microbiota, making it less susceptible to microbial fluctuations than the control group. Trial registration: ClinicalTrials.gov (NCT05999175). Competing Interests: Dionisio Franco Barattini is employed at Tigermed (formerly Opera CRO Romania), the contract research organization that performed data management for the study. Paola Benatti is employed at Alfasigma, owner and distributor of the Tau-Marin products line tested in this study. The other authors report no potential conflicts of interest. |
| فهرسة مساهمة: | Keywords: manual toothbrush; mouthwash; oral hygiene; oral microbiota stability; paraprobiotics; prebiotics; toothpaste |
| سلسلة جزيئية: | ClinicalTrials.gov NCT05999175 |
| المشرفين على المادة: | 0 (Mouthwashes) 0 (Toothpastes) |
| تواريخ الأحداث: | Date Created: 20240621 Date Completed: 20240621 Latest Revision: 20240621 |
| رمز التحديث: | 20240622 |
| PMID: | 38905608 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 0363-6771 |
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