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Xylitol gummy bear snacks: a school-based randomized clinical trial.

ABSTRACT: Habitual consumption of xylitol reduces mutans streptococci (MS) levels but the effect on Lactobacillus spp. is less clear. Reduction is dependent on daily dose and frequency of consumption. For xylitol to be successfully used in prevention programs to reduce MS and prevent caries, effective xylitol delivery methods must be identified. This study examines the response of MS, specifically S. mutans/sobrinus and Lactobacillus spp., levels to xylitol delivered via gummy bears at optimal exposures.Children, first to fifth grade (n = 154), from two elementary schools in rural Washington State, USA, were randomized to xylitol 15.6 g/day (X16, n = 53) or 11.7 g/day (X12, n = 49), or maltitol 44.7 g/day (M45, n = 52). Gummy bear snacks were pre-packaged in unit-doses, labeled with ID numbers, and distributed three times/day during school hours. No snacks were sent home. Plaque was sampled at baseline and six weeks and cultured on modified Mitis Salivarius agar for S. mutans/sobrinus and Rogosa SL agar for Lactobacillus spp. enumeration.There were no differences in S. mutans/sobrinus and Lactobacillus spp. levels in plaque between the groups at baseline. At six weeks, log10 S. mutans/sobrinus levels showed significant reductions for all groups (p = 0.0001): X16 = 1.13 (SD = 1.65); X12 = 0.89 (SD = 1.11); M45 = 0.91 (SD = 1.46). Reductions were not statistically different between groups. Results for Lactobacillus spp. were mixed. Group X16 and M45 showed 0.31 (SD = 2.35), and 0.52 (SD = 2.41) log10 reductions, respectively, while X12 showed a 0.11 (SD = 2.26) log10 increase. These changes were not significant. Post-study discussions with school staff indicated that it is feasible to implement an in-classroom gummy bear snack program. Parents are accepting and children willing to consume gummy bear snacks daily.Reductions in S. mutans/sobrinus levels were observed after six weeks of gummy bear snack consumption containing xylitol at 11.7 or 15.6 g/day or maltitol at 44.7 g/day divided in three exposures. Lactobacillus spp. levels were essentially unchanged in all groups. These results suggest that a xylitol gummy bear snack may be an alternative to xylitol chewing gum for dental caries prevention. Positive results with high dose maltitol limit the validity of xylitol findings. A larger clinical trial is needed to confirm the xylitol results.[ISRCTN63160504].

SUBMITTER: Ly KA

PROVIDER: S-EPMC2527560 | biostudies-literature | 2008 Jul

REPOSITORIES: biostudies-literature

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Xylitol gummy bear snacks: a school-based randomized clinical trial.

Ly Kiet A KA Riedy Christine A CA Milgrom Peter P Rothen Marilynn M Roberts Marilyn C MC Zhou Lingmei L

BMC oral health 20080725

<h4>Background</h4>Habitual consumption of xylitol reduces mutans streptococci (MS) levels but the effect on Lactobacillus spp. is less clear. Reduction is dependent on daily dose and frequency of consumption. For xylitol to be successfully used in prevention programs to reduce MS and prevent caries, effective xylitol delivery methods must be identified. This study examines the response of MS, specifically S. mutans/sobrinus and Lactobacillus spp., levels to xylitol delivered via gummy bears at ...[more]

PMID: 18657266

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Project description:ImportanceSchool-based interventions offer an opportunity for health promotion in adolescence.ObjectiveTo assess the effect of 2 multicomponent educational health promotion strategies of differing duration and intensity on adolescents' cardiovascular health (CVH).Design, setting, and participantsThe SI! Program for Secondary Schools is a 4-year cluster randomized clinical intervention trial conducted in 24 secondary schools from Barcelona and Madrid, Spain, from September 7, 2017, to July 31, 2021. Eligible participants were adolescents enrolled in the first grade of secondary school.InterventionsSchools and their participants were randomized to receive a health promotion intervention (SI! Program) over 4 school years (long-term intervention [LTI], 8 schools, 412 adolescents) or 2 school years (short-term intervention [STI], 8 schools, 504 adolescents) or to receive the standard curriculum (control, 8 schools, 441 adolescents).Main outcome and measuresThe primary end point was the between-group difference at 2 and 4 years in the change from baseline of the overall CVH score, as defined by the American Heart Association (range, 0-14 points, with a higher score indicating a healthier CVH profile). Intervention effects were tested with multilevel mixed-effects models. A complete-case intention-to-treat analysis was performed as the primary analysis.ResultsOf the randomized students, the study enrolled 1326 adolescents (684 [51.6%] boys, mean [SD] age, 12.5 [0.4] years at recruitment) with a study completion rate of 86.0%. Baseline overall CVH scores were 10.3 points in the LTI group, 10.6 points in the STI group, and 10.5 points in the control group. After 2 years, at halfway through the LTI and at the end of the STI, the difference in the CVH score change was 0.44 points (95% CI, 0.01-0.87; P = .04) between the LTI group and the control group and 0.18 points (95% CI, -0.25 to 0.61; P = .39) between the STI group and the control group. At 4 years, differences for the LTI and STI groups vs control were 0.12 points (LTI: 95% CI, -0.19 to 0.43; P = .42) and 0.13 points (STI: 95% CI, -0.17 to 0.44; P = .38). No adverse events were reported.Conclusions and relevanceOverall, the tested school-based health promotion strategies in this randomized clinical trial had a neutral effect on the CVH of the adolescents. Although there was evidence of a marginal beneficial effect at a point halfway through implementation in the LTI group, such a benefit was not noted at 4 years. Further research is warranted into the efficacy of school-based health promotion programs.Trial registrationClinicalTrials.gov Identifier: NCT03504059.

Project description:ObjectivesTo evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children and to evaluate the effect of xylitol in reducing acute otitis media in a subsequent study.DesignDouble-blind randomized controlled trial.SettingCommunities in the Republic of the Marshall Islands.ParticipantsOne hundred eight children aged 9 to 15 months were screened, and 100 were enrolled. Intervention Children were randomized to receive xylitol topical oral syrup (administered by their parents) twice a day (2 xylitol [4.00-g] doses and 1 sorbitol dose) (Xyl-2 x group) or thrice per day (3 xylitol [2.67-g] doses) (Xyl-3x group) vs a control syrup (1 xylitol [2.67-g] dose and 2 sorbitol doses) (control group).Main outcome measuresThe primary outcome end point of the study was the number of decayed primary teeth. A secondary outcome end point was the incidence of acute otitis media for reporting in a subsequent report.ResultsNinety-four children (mean [SD] age, 15.0 [2.7] months at randomization) with at least 1 follow-up examination were included in the intent-to-treat analysis. The mean (SD) follow-up period was 10.5 (2.2) months. Fifteen of 29 of the children in the control group (51.7%) had tooth decay compared with 13 of 32 children in the Xyl-3x group (40.6%) and eight of 33 children in the Xyl-2x group (24.2%). The mean (SD) numbers of decayed teeth were 1.9 (2.4) in the control group, 1.0 (1.4) in the Xyl-3x group, and 0.6 (1.1) in the Xyl-2x group. Compared with the control group, there were significantly fewer decayed teeth in the Xyl-2x group (relative risk, 0.30; 95% confidence interval, 0.13-0.66; P = .003) and in the Xyl-3x group (0.50; 0.26-0.96; P = .04). No statistical difference was noted between the 2 xylitol treatment groups (P = .22).ConclusionXylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in preventing early childhood caries.

Project description:ImportanceAnnually, US schools screen millions of students' body mass index (BMI) and report the results to parents, with little experimental evidence on potential benefits and harms.ObjectiveTo determine the impact of school-based BMI reporting on weight status and adverse outcomes (weight stigmatization and weight-related perceptions and behaviors) among a diverse student population.Design, setting, and participantsCluster randomized clinical trial. The Fit Study (2014-2017) randomized 79 California schools to BMI screening and reporting (group 1), BMI screening only (group 2), or control (no BMI screening or reporting [group 3]) in grades 3 to 8. The setting was California elementary and middle schools. Students in grades 3 to 7 at baseline participated for up to 3 years. A modified intent-to-treat protocol was used. Data analysis was conducted from April 13, 2017, to March 26, 2020.InterventionsSchool staff assessed BMI each spring among students in groups 1 and 2. Parents of students in group 1 were sent a BMI report each fall for up to 2 years.Main outcomes and measuresChanges in BMI z score and in adverse outcomes (based on surveys conducted each fall among students in grades 4 to 8) from baseline to 1 and 2 years of follow-up.ResultsA total of 28 641 students (14 645 [51.1%] male) in grades 3 to 7 at baseline participated in the study for up to 3 years. Among 6534 of 16 622 students with a baseline BMI in the 85th percentile or higher (39.3%), BMI reporting had no effect on BMI z score change (-0.003; 95% CI, -0.02 to 0.01 at 1 year and 0.01; 95% CI, -0.02 to 0.03 at 2 years). Weight dissatisfaction increased more among students having BMI screened at school (8694 students in groups 1 and 2) than among control participants (5674 students in group 3). Results of the effect of BMI reporting on other adverse outcomes were mixed: compared with the control (group 3), among students weighed at school (groups 1 and 2), weight satisfaction declined more after 2 years (-0.11; 95% CI, -0.18 to -0.05), and peer weight talk increased more after 1 year (0.05; 95% CI, 0.01-0.09); however, concerning weight control behaviors declined more after 1 year (-0.06; 95% CI, -0.10 to -0.02).Conclusions and relevanceBody mass index reports alone do not improve children's weight status and may decrease weight satisfaction. To improve student health, schools should consider investing resources in evidence-based interventions.Trial registrationClinicalTrials.gov Identifier: NCT02088086.

Project description:ImportanceDental caries is the most common global childhood disease. To control caries, the Centers for Disease Control and Prevention recommends school-based caries prevention, and the World Health Organization lists glass ionomer cement and silver diamine fluoride as essential medicines for oral disease.ObjectiveTo determine the noninferiority of silver diamine fluoride with fluoride varnish vs traditional glass ionomer sealants with fluoride varnish after 2 years when provided to children via a school-based health care program.Design, setting, and participantsThe CariedAway study is an ongoing single-blind, cluster randomized, noninferiority trial conducted between February 1, 2019, and June 1, 2023, among 2998 children in 47 New York City primary schools. Children aged 5 to 13 years of any race and ethnicity were recruited from block-randomized schools. Inclusion criteria for schools were a student population of at least 50% Hispanic or Latino or Latina ethnicity and/or Black race and at least 80% of students receiving free or reduced-cost lunch. Statistical analysis is reported through March 2022.InterventionsChildren received a single application of silver diamine fluoride with fluoride varnish or an active comparator of glass ionomer sealants and atraumatic restorations with fluoride varnish.Main outcomes and measuresPrimary outcomes were caries arrest and incidence after a 2-year follow-up, assessed using mixed-effects multilevel models and clustered 2-sample proportion tests. The noninferiority margin was 10%. Intention-to-treat analysis was performed using multiple imputation.ResultsA total of 2998 children (1566 girls [52.2%]; mean [SD] age at baseline, 6.6 [1.2] years; 1397 Hispanic or Latino or Latina children [46.6%]; 874 [29.2%] with untreated dental caries) were recruited and treated from September 16, 2019, to March 12, 2020. Follow-up observations were completed for 1398 children from June 7, 2021, to March 2, 2022. The mean (SE) proportion of children with arrested caries was 0.56 (0.04) after experimental treatment and 0.46 (0.04) after control treatment (difference, -0.11; 95% CI, -0.22 to 0.01). The mean (SE) proportion of patients without new caries was 0.81 (0.02) after experimental treatment and 0.82 (0.02) after control treatment (difference, 0.01; 95% CI, -0.04 to 0.06). Analysis of imputed data for the full sample did not deviate from per-protocol analyses. There were no adverse events.Conclusions and relevanceIn this randomized clinical trial, silver diamine fluoride with fluoride varnish was noninferior to sealants and atraumatic restorations with fluoride varnish for caries arrest and prevention. Results may support the use of silver diamine fluoride as an arresting and preventive agent in school-based oral health programs.Trial registrationClinicalTrials.gov Identifier: NCT03442309.

Project description:BACKGROUND:Afterschool interventions have been found to improve the nutritional quality of snacks served. However, there is limited evidence on how these interventions affect children's snacking behaviors. OBJECTIVE:Our aim was to determine the impact of an afterschool intervention focused at the school district, site, family, and child levels on dietary consumption of foods and beverages served at snack. DESIGN:This was a secondary analysis of a group-randomized controlled trial. PARTICIPANTS/SETTING:Data were collected from 400 children at 20 afterschool sites in Boston, MA before (fall 2010) and after (spring 2011) intervention implementation. INTERVENTION:The Out-of-School Nutrition and Physical Activity intervention aimed to promote fruits, vegetables, whole grains, and water, while limiting sugary drinks and trans fats. Researchers worked with district foodservice staff to change snack foods and beverages. Teams of afterschool staff participated in three 3-hour learning collaborative sessions to build skills and created action plans for changing site practices. The intervention included family and child nutrition education. MAIN OUTCOME MEASURES:Research assistants observed dietary snack consumption using a validated measure on 2 days per site at baseline and follow-up. STATISTICAL ANALYSES PERFORMED:This study used multivariable regression models, accounting for clustering of observations, to assess the intervention effect, and conducted post-hoc stratified analyses by foodservice type. RESULTS:Children in intervention sites had greater decreases in consumption of juice (-0.61 oz/snack, 95% CI -1.11 to -0.12), beverage calories (-29.1 kcal/snack, 95% CI -40.2 to 18.0), foods with trans fats (-0.12 servings/snack, 95% CI -0.19 to -0.04), total calories (-47.7 kcal/snack, 95% CI -68.2 to -27.2), and increases in consumption of whole grains (0.10 servings/snack, 95% CI 0.02 to 0.18) compared to controls. In post-hoc analyses, sites with on-site foodservice had significant improvements for all outcomes (P<0.001), with no effect for sites with satellite foodservice. CONCLUSIONS:Results demonstrate that an afterschool intervention can improve children's dietary snack consumption, particularly at sites with on-site foodservice.

Project description:Repetition and reinforcement have been shown to play a crucial role in the sustainability of the effect of Oral Health Education (OHE) programs. However, its relevance to school-based OHE imparted by different personnel is not depicted by the existing dental literature. The present study was undertaken to determine the effectiveness of the repeated and reinforced OHE (RR-OHE) compared to one-time OHE intervention and to assess its role in school-based OHE imparted by dentist, teachers and peers.The study was a cluster randomized controlled trial that involved 935 adolescents aged 10-11 years. Twenty four boys' and girls' schools selected at random in two towns of Karachi, Pakistan were randomly assigned to three groups to receive OHE by dentist (DL), teachers (TL) and peer-leaders (PL). The groups received a single OHE session and were evaluated post-intervention and 6 months after. The three groups were then exposed to OHE for 6 months followed by 1 year of no OHE activity. Two further evaluations at 6-month and 12-month intervals were conducted. The data were collected by a self-administered questionnaire preceded by a structured interview and followed by oral examination of participants.The adolescents' oral health knowledge (OHK) in the DL and PL groups increased significantly by a single OHE session compared to their baseline knowledge (p < 0.05) and the increase was sustained over 6 months. Although one-time OHE resulted in a significant improvement in adolescents' oral health behavior (OHB) related to the prevention of gingivitis in the two groups (p < 0.05), no significant change was observed in their behavior towards prevention of oral cancer. One-time teacher-led OHE was ineffective in improving adolescents' OHK and OHB. The oral hygiene status (OHS) of the participants in all three groups did not change statistically after one-time OHE. The OHK, OHB and OHS indices increased significantly 6 months after RR-OHE than the initial scores (p < 0.001) irrespective of OHE strategy. Although the OHK scores of the DL and PL groups decreased significantly at 12-month evaluation of RR-OHE (p < 0.05), the said score of the TL group; and OHB and OHS scores of all three groups remained statistically unchanged during this period.The repetition and reinforcement play a key role in school-based OHE irrespective of educators. The trained teachers and peers can play a complementary role in RR-OHE.

Project description:BackgroundXylitol use is reported to be able to reduce dental plaque amount and cariogenic bacteria and, as a consequence, the caries increment. Only few data on the oral health of Ladakh's population are available. The aim of the present protocol will be to record the caries prevalence of primary and permanent molars of schoolchildren living in Ladakh and to implement a school-based Xylitol programme, named the Caries Prevention Xylitol in Children (CaPreXCh) trial, using chewing gums.MethodsThe protocol is designed as a triple-blind randomized, controlled, parallel-group clinical trial in children aged 5-14 years. The study should have been carried out from August 2021 to August 2024 in Zanskar Valley (Ladakh), but the COVID-19 pandemic does not allow today to make predictions on the exact start. Participants will be randomly allocated into two groups: subjects who will receive a chewing gum with Xylitol (70% w/v) as only sweetener, and those who will receive a sugared chewing gum containing Maltitol (23% w/v). The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon) for one school year. Clinical examination will comprise an oral examination in which caries index (ICDAS scores), bleeding on probing and plaque pH evaluation after sucrose challenge will be recorded at baseline (t0); the clinical examination will be repeated after 12 months since the beginning of the chewing gum administration period (t1), after another 12-month period (t2) and finally after further 12 months (t3) (24 months from the end of the chewing gum use). The primary outcome will be the caries increment measured both at enamel and dentinal levels on primary and permanent molars. Data analysis will be conducted through Kaplan-Meyer graphs to evaluate caries increment. A comparison of the methods will be carried out with Cox regression with shared frailty. The net caries increment for initial, moderate and severe caries levels, using ICDAS (Δ-initial, Δ-moderate and Δ-severe), will be calculated.DiscussionThis trial will be the first trial conducted in India assessing the efficacy of a school-based caries preventive programme through the use of chewing gum containing only Xylitol as a sweetener. The findings could help strengthen the evidence for the efficacy of Xylitol use in community-based caries prevention programmes in children.Trial registrationClinical trials.gov NCT04420780 . Registered on June 9, 2020.

Dataset Information

Xylitol gummy bear snacks: a school-based randomized clinical trial.

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Xylitol gummy bear snacks: a school-based randomized clinical trial.

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