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Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial.

ABSTRACT: To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area.The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138 healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test group were instructed to give their child one chewing tablet per day containing three strains of live probiotic bacteria (ProBiora3) and the placebo group got identical tablets without bacteria. The duration was one year and the prevalence and increment of initial and manifest caries lesions was examined at baseline and follow-up. All parents were thoroughly instructed to brush the teeth of their off-springs twice daily with fluoride toothpaste.The groups were balanced at baseline and the attrition rate was 20%. Around 2/3 of the children in both groups reported an acceptable compliance. The caries increment (?ds) was significantly lower in the test group when compared with the placebo group, 0.2 vs. 0.8 (p?

SUBMITTER: Hedayati-Hajikand T

PROVIDER: S-EPMC4583156 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial.

Hedayati-Hajikand Trifa T Lundberg Ulrika U Eldh Catarina C Twetman Svante S

BMC oral health 20150924 1

<h4>Background</h4>To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area.<h4>Methods</h4>The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138 healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test g ...[more]

PMID: 26403472

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Project description:IntroductionCaries experience among preschool-age children has remained relatively unchanged for the past 2 decades, despite recently documented decreases in untreated decay.ObjectivesIn a community-based cluster-randomized controlled trial, a motivational interviewing (MI) intervention administered to primary caregivers was hypothesized to reduce caries increment over 2 y as compared with controls, among children aged 0 to 5 y at baseline living in public housing.MethodsPublic housing residents, who served as interventionists, were trained in MI with a focus on early childhood caries prevention. All 26 eligible public housing developments were randomized to either control (quarterly clinical examinations, fluoride varnish applications, toothbrush/toothpaste, and educational brochures) or intervention (same procedures as control plus MI counseling). Quarterly MI sessions were delivered in English or Spanish over 2 y, audio recorded, and assessed for treatment fidelity. The primary outcome was the increment in dmfs (decayed, missing, and filled tooth surfaces) as assessed by clinical examination at baseline, 12 mo, and 24 mo. Secondary outcomes included caregiver oral health knowledge and child oral health behaviors (child toothbrushing and sugar-sweetened beverage intake). Baseline characteristics were compared between groups and adjusted for housing-site clusters. Longitudinal outcomes were analyzed with mixed models.ResultsA total of 1,065 children (49% female, 55% non-White, 61% Hispanic, 89% below poverty level, n = 686 control) and their caregivers were enrolled. During 2 y of follow-up, the mean dmfs increment increased in both groups; however, there were no statistically significant group differences at 24 mo or group × time interactions. The mean increase in intervention caregivers' knowledge was significantly greater than that of control, F(2, 1,593) = 3.48, P = 0.0310, but there were no significant intervention effects on caregiver-reported child sugar-sweetened beverage intake or child toothbrushing.ConclusionMI counseling plus intensive caries prevention activities resulted in knowledge increases but did not improve oral health behaviors or caries increment (ClinicalTrials.gov NCT01205971).Knowledge transfer statementWhen viewed in light of the findings from the companion Pine Ridge study and other recent MI studies, the results of this study suggest that when the complex disease of early childhood caries is addressed in high-risk populations, MI is not effective, and alternative approaches are warranted.

Project description:Introduction:In a randomized controlled trial, the effectiveness of motivational interviewing (MI) combined with enhanced community services (MI + ECS) was compared with ECS alone for reducing dental caries in American Indian children on the Pine Ridge Reservation. The intervention was developed and delivered with extensive tribal collaboration. Methods:A total 579 mother-newborn dyads were enrolled and randomized to the MI + ECS and ECS groups. They were followed for 36 mo. Four MI sessions were provided, the first shortly after childbirth and then 6, 12, and 18 mo later. Both groups were exposed to ECS, which included public service announcements through billboards and tribal radio, as well as broad distribution of brochures on behavioral risk factors for early childhood caries (ECC), toothbrushes, and toothpaste. MI impact was measured as decayed, missing, and filled tooth surfaces (dmfs). Secondary outcomes included decayed surfaces, caries prevalence, and maternal oral health knowledge and behaviors. Modified intention-to-treat analyses were conducted. Eighty-eight percent of mothers completed at least 3 of 4 MI sessions offered. Results:After 3 y, dmfs was not significantly different for the 2 groups (MI + ECS = 10, ECS = 10.38, P = 0.68). In both groups, prevalence of caries experience was 7% to 9% after 1 y, 35% to 36% at 2 y, and 55% to 56% at 3 y. Mean knowledge scores increased by 5.0, 5.3, and 5.9 percentage points at years 1, 2, and 3 in the MI + ECS group and by 1.9, 3.3, and 5.0 percentage points in the ECS group (P = 0.03), respectively. Mean maternal oral health behavior scores were not statistically significantly different between the treatment arms. Conclusion:In summary, the MI intervention appeared to improve maternal knowledge but had no effect on oral health behaviors or on the progression of ECC (ClinicalTrials.gov NCT01116726). Knowledge Transfer Statement:The findings of this study suggest that motivational interviewing focusing on parental behaviors may not be as effective as previously hoped for slowing the development of childhood caries in some high-risk groups. Furthermore, social factors may be even more salient determinants of oral health than what we previously supposed, perhaps interfering with the capacity to benefit from behavioral strategies that have been useful elsewhere. The improvement of children's oral health in high-risk populations characterized by poverty and multiple related life stresses may require more holistic approaches that address these formidable barriers.

Project description:BACKGROUND:In 2017, approximately 3.7 billion downloads of health apps were made on mobile phones and tablets. In this sense, a massive number of people could benefit by electronic mobile-based health interventions, making information available even with the lack of material and human resources. Hence, the use of electronic apps for dental education might be extremely useful for the prevention of early childhood caries (ECC). OBJECTIVE:This study aims to evaluate the effectiveness of messages sent via mobile phones as an adjuvant method for the prevention of ECC. METHODS:A single-blinded, randomized, and parallel-group clinical trial will be conducted with dyads of parents or caregivers and children aged between 36 and 60 months, recruited from kindergartens and schools of Bauru, São Paulo. The determination of sample size resulted in a total of 104 dyads of parents and children, considering a power of 80%, a significance level of 5%, and an attrition of 30%. This sample will be randomly assigned to test and control groups, being divided in 52 dyads per group according to the health literacy levels of parents and the age, gender, and oral health status of children. Every 2 weeks, only participants in the test group will receive messages via WhatsApp containing preventive and education-related ECC information. The dyads will visit the dentist every 3 months during a year for the assessment of primary outcomes (sugar consumption and the International Caries Detection and Assessment System, visible plaque, and community periodontal indices) and to receive dental care measures. Secondary outcomes (electronic health literacy and general perceived self-efficacy) will be determined only at baseline and after 12-month follow-up. The quality of randomization will be evaluated throughout the study, comparing the test and control groups systematically by Student t tests for continuous variables and chi-square tests for categorical variables. Listwise deletion method will be applied in cases of dropouts, if the missing values satisfy the criteria of missing completely at random; otherwise, multiple imputation data strategy will be conducted. The Kolmogorov-Smirnov and Levene tests will be used to determine the normality and homogeneity of data, respectively, which will indicate further statistical analyses for elucidating significant differences between groups (P<.05). A Student t test or Mann-Whitney U test will be employed for parametric or nonparametric analyses, respectively. RESULTS:The project was funded in 2018, and enrollment was completed in August 2019. Allocation is currently under way and the first results are expected to be submitted for publication in 2020. CONCLUSIONS:The results will contribute to understanding the importance of educational mobile messages toward the adoption of healthy behaviors for the prevention of ECC in a given population. TRIAL REGISTRATION:Brazilian Registry of Clinical Trials Universal Trial Number U1111-1216-1393; http://www.ensaiosclinicos.gov.br/rg/RBR-2b6r7q/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/13656.

Dataset Information

Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial.

Publications

Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial.

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