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Early Childhood Caries clinical trials

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NCT ID: NCT03077425 Completed - Pediatric Obesity Clinical Trials

Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach

CHALO
Start date: December 7, 2017
Phase: N/A
Study type: Interventional

The CHALO ("Child Health Action to Lower Oral Caries and Obesity") -- from an Urdu word meaning "Let's go!"-is a multi-level strategy to reduce pediatric obesity and dental caries risk in South Asian (SA) children. Obesity and caries are the two most prominent health disparities of early childhood. Both caries and obesity: a) disproportionately impact low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c) can most effectively be reduced or prevented prevention in infancy and early childhood. SA immigrant children are at high risk for both. CHALO includes both a randomized controlled trial (RCT) aimed at reducing risk behavior, and a Knowledge Translation project to raise awareness in SA lay and professional communities regarding child health risks.

NCT ID: NCT02487043 Completed - Clinical trials for Early Childhood Caries

A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries

Start date: August 2015
Phase: N/A
Study type: Interventional

Despite improvements in oral health among children, children living in areas characterized by low socio-economic status still have a significant disease burden with regard to dental caries. Special efforts to prevent disease development in this group of children have been unsuccessful. Small children with extensive treatment needs often have limited abilities to cooperate and to provide quality dental care in this patient group, general aneaethesia (GA) may often be the treatment modality of choice. Preschool children treated under general anesthesia have significantly higher caries prevalence (deft and defs), apical parodontitis and infection due to pulpal necrosis. They also have significantly more emergency visits and previous use of treatment under sedation. This study aim to test the hypothesis, that a telephone based case management intervention for children with severe early childhood caries can prevent further caries development in preschool children who are treated under general anesthesia for severe early childhood caries.

NCT ID: NCT02385474 Completed - Clinical trials for Early Childhood Caries

Effectiveness of SDF in Arresting Dental Caries in Preschool Children

Start date: March 2013
Phase: Phase 3
Study type: Interventional

Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood disease. Poor dentition significantly affects the nutrition, growth, development and general health of children. Conventional dental care for ECC is neither affordable nor accessible, particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe, cost-effective caries-arresting agent that appears to conform to the World Health Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an evidence base. Therefore it is necessary to find the most suitable SDF concentration and application interval to arrest ECC. The purpose of this randomised controlled trial is to compare the efficacy of two commercially available SDF solutions at pre-prepared concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months in arresting caries in primary teeth. Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4 years with caries. The sample size is sufficient for the appropriate statistical analyses. The children were classified into high and low caries rates and equally allocated into four groups for the caries treatment: Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children will be followed for 36 months in their kindergartens until they enter primary school. Clinical examinations at 6-month intervals will be conducted to assess whether the caries are arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and follow-ups. Discussion: This study will help determine the most suitable SDF concentration and application interval to arrest caries in children. Because SDF use for caries arrest is painless, simple, and low-cost, it can be widely recommended and promoted for caries control in young children or those with difficulty accessing and affording conventional dental care. The applicability of the findings and their impact on public health would be immense.

NCT ID: NCT02019160 Completed - Clinical trials for Early Childhood Caries

Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish

Start date: September 2014
Phase: Phase 3
Study type: Interventional

- Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period. - Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire. - Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.

NCT ID: NCT01795222 Completed - Clinical trials for Early Childhood Caries

Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Pedsed-I
Start date: March 2012
Phase: Phase 4
Study type: Interventional

Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment