K Bansal, A Shamoo, S Mohapatra, M Kalaivani, P Batra, V P Mathur, A Srivastava, R Chaudhry
{"title":"蔓越莓萃取物和氟化钠漱口水对儿童口腔中变异杆菌数量的比较评估：双盲随机对照试验。","authors":"K Bansal, A Shamoo, S Mohapatra, M Kalaivani, P Batra, V P Mathur, A Srivastava, R Chaudhry","doi":"10.1007/s40368-024-00939-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Recently, research in the field of caries prevention is emphasizing upon identification of edible non-toxic compounds that can interfere with the formation of cariogenic biofilm.</p><p><strong>Aim: </strong>This trial aimed to assess the effectiveness of non-dialyzable material (NDM) containing cranberry mouth rinse (C-MR) on the Streptococcus mutans (S. mutans) counts and compare with that of a sodium fluoride (F-MR) mouth rinse.</p><p><strong>Methods: </strong>280 children (8-12 years old) were enrolled in this double-blind single center, parallel, one-month, IRB/IEC approved non-inferiority trial. The participants fulfilling the inclusion criteria were randomly allocated into one of the two groups: C-MR and F-MR. All participants were given verbal and written instructions about at-home mouth-rinsing regimen under parental supervision for a month. Dental plaque samples were collected before and after a month of mouth-rinsing and subjected to culture techniques. S. mutans counts were assessed and compared in both groups. Primary outcome was the difference in the S. mutans counts between two interventions. Both intention-to-treat (ITT) and per-protocol analysis were carried out using two-sample t test with equal variance.</p><p><strong>Results: </strong>The mean S. mutans counts (after log transformation) in C-MR group were: 14.66 (90% CI 14.4,14.9) at baseline and 12.85 (90% CI 12.5, 13.2) colony-forming units/ml (CFU/ml) at one-month post intervention (p = 0.001); while these counts were 14.69 (90% CI 14.5, 14.9) at baseline and 12.71 (90% CI 12.3, 13.1) at one-month intervention in F-MR groups (p = 0.001). ITT analysis showed an inter- group difference of 0.14 CFU/ml (90% CI - 0.32,0.59) in post-SM counts between groups (p = 0.629).</p><p><strong>Conclusion: </strong>The study demonstrated that the cranberry mouth rinse was non-inferior to the fluoride mouth rinse in terms of S. mutans levels change. 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The participants fulfilling the inclusion criteria were randomly allocated into one of the two groups: C-MR and F-MR. All participants were given verbal and written instructions about at-home mouth-rinsing regimen under parental supervision for a month. Dental plaque samples were collected before and after a month of mouth-rinsing and subjected to culture techniques. S. mutans counts were assessed and compared in both groups. Primary outcome was the difference in the S. mutans counts between two interventions. Both intention-to-treat (ITT) and per-protocol analysis were carried out using two-sample t test with equal variance.</p><p><strong>Results: </strong>The mean S. mutans counts (after log transformation) in C-MR group were: 14.66 (90% CI 14.4,14.9) at baseline and 12.85 (90% CI 12.5, 13.2) colony-forming units/ml (CFU/ml) at one-month post intervention (p = 0.001); while these counts were 14.69 (90% CI 14.5, 14.9) at baseline and 12.71 (90% CI 12.3, 13.1) at one-month intervention in F-MR groups (p = 0.001). ITT analysis showed an inter- group difference of 0.14 CFU/ml (90% CI - 0.32,0.59) in post-SM counts between groups (p = 0.629).</p><p><strong>Conclusion: </strong>The study demonstrated that the cranberry mouth rinse was non-inferior to the fluoride mouth rinse in terms of S. mutans levels change. 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引用次数: 0
摘要
背景：目的：本试验旨在评估含有蔓越莓的非二硝基材料（NDM）漱口水（C-MR）对变异链球菌（S. mutans）计数的有效性，并与氟化钠漱口水（F-MR）进行比较。方法：280 名儿童（8-12 岁）参加了这项经 IRB/IEC 批准的双盲、单中心、平行、为期一个月的非劣效性试验。符合纳入标准的参与者被随机分配到两组中的一组：C-MR组和F-MR组。所有参与者都在家长的监督下接受了为期一个月的有关居家漱口方法的口头和书面指导。在漱口一个月前后收集牙菌斑样本并进行培养。评估并比较两组的变异杆菌数量。主要结果是两种干预措施之间变异杆菌数量的差异。采用等方差双样本 t 检验法进行意向治疗（ITT）和按协议分析：结果：C-MR 组的平均 S. mutans 计数（对数变换后）为 14.66（90% CI）：基线时为 14.66（90% CI 14.4,14.9），干预后一个月时为 12.85（90% CI 12.5,13.2）个菌落形成单位/毫升（CFU/ml）（P = 0.001）；而 F-MR 组的基线时和干预后一个月时的平均菌落形成单位/毫升数分别为 14.69（90% CI 14.5,14.9）和 12.71（90% CI 12.3,13.1）（P = 0.001）。ITT 分析表明，各组间的后SM计数差异为 0.14 CFU/ml (90% CI - 0.32,0.59)（p = 0.629）：研究结果表明，就变异单胞菌水平的变化而言，蔓越莓漱口水并不比氟化物漱口水差。蔓越莓漱口水可有效降低儿童的变异杆菌数量：临床试验注册号：CTRI/2019/05/019395。
Comparative evaluation of cranberry extract and sodium fluoride as mouth rinses on S. mutans counts in children: a double-blind randomized controlled trial.
Background: Recently, research in the field of caries prevention is emphasizing upon identification of edible non-toxic compounds that can interfere with the formation of cariogenic biofilm.
Aim: This trial aimed to assess the effectiveness of non-dialyzable material (NDM) containing cranberry mouth rinse (C-MR) on the Streptococcus mutans (S. mutans) counts and compare with that of a sodium fluoride (F-MR) mouth rinse.
Methods: 280 children (8-12 years old) were enrolled in this double-blind single center, parallel, one-month, IRB/IEC approved non-inferiority trial. The participants fulfilling the inclusion criteria were randomly allocated into one of the two groups: C-MR and F-MR. All participants were given verbal and written instructions about at-home mouth-rinsing regimen under parental supervision for a month. Dental plaque samples were collected before and after a month of mouth-rinsing and subjected to culture techniques. S. mutans counts were assessed and compared in both groups. Primary outcome was the difference in the S. mutans counts between two interventions. Both intention-to-treat (ITT) and per-protocol analysis were carried out using two-sample t test with equal variance.
Results: The mean S. mutans counts (after log transformation) in C-MR group were: 14.66 (90% CI 14.4,14.9) at baseline and 12.85 (90% CI 12.5, 13.2) colony-forming units/ml (CFU/ml) at one-month post intervention (p = 0.001); while these counts were 14.69 (90% CI 14.5, 14.9) at baseline and 12.71 (90% CI 12.3, 13.1) at one-month intervention in F-MR groups (p = 0.001). ITT analysis showed an inter- group difference of 0.14 CFU/ml (90% CI - 0.32,0.59) in post-SM counts between groups (p = 0.629).
Conclusion: The study demonstrated that the cranberry mouth rinse was non-inferior to the fluoride mouth rinse in terms of S. mutans levels change. Cranberry-based mouth rinse can be used effectively to reduce the S. mutans counts in children.
Trial registration: Registration number in case of Clinical Trials-CTRI/2019/05/019395.
期刊介绍：
The aim and scope of European Archives of Paediatric Dentistry (EAPD) is to promote research in all aspects of dentistry for children, including interceptive orthodontics and studies on children and young adults with special needs. The EAPD focuses on the publication and critical evaluation of clinical and basic science research related to children. The EAPD will consider clinical case series reports, followed by the relevant literature review, only where there are new and important findings of interest to Paediatric Dentistry and where details of techniques or treatment carried out and the success of such approaches are given.
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