[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-childhood-caries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-childhood-caries":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,77,110,134,156],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100497742","oropharyngeal-candidiasis-opc-and-s-ecc-100497742",false,"NCT05761197","Oropharyngeal Candidiasis (OPC) and S-ECC","Association Between Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)","Oral-Thrush","Inclusion Criteria:\n\n* Male or female individuals at the age of 9-15-month-old\n* Must have at least one fully erupted tooth at baseline visit\n* Parent\u002Fguardian willing and able to provide informed consent\n* With or without a history of OPC (the study team will enroll 35 participants with and 35 participants without a history of OPC)\n\nExclusion Criteria:\n\n* Presence of a systemic medical condition (e.g. Down syndrome etc.)\n* Presence of an orofacial deformity\n* Presence of dental caries\n* Use of systemic antimicrobial therapy within 30 days of the baseline visit\n* Presence of any condition which, in the opinion of the investigator, makes participation in the project not in the individual's best interest.",true,"ALL","9 Months","15 Months",{"count":22,"type":23},70,"ESTIMATED","OBSERVATIONAL","The overall objective of this study is to investigate the association of early Candida infection (known as oral thrush or oropharyngeal candidiasis, OPC) in children during the first year of life with the onset and severity of severe early childhood caries (S-ECC).",[27,28,29],"Candida Infection","Oral Thrush","Early Childhood Caries",[31,32,33,34,35],"Oral candidiasis","Candida infection","Oral thrush","Early childhood caries","Oral Health","RECRUITING","2026-06-18",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":40},"2024-09-01",{"date":44,"type":23},"2028-08-31",{"name":46,"class":47},"Temple University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100609920","oral-health-intervention-for-caregivers-of-children-presenting-for-dental-surgery-100609920","NCT07220850","Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery","Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population","PROTECT","Inclusion Criteria:\n\n* caregivers of child patients who are in the same household greater than or equal to 50% of the week\n* caregivers aged 18-90 years\n* caregivers with access to a computer or a telephone\n* child patients that are less than 96 months of age at the time of enrollment scheduled for DGA at the UIC clinic\n\nExclusion Criteria:\n\n* surgical child is foster status\n* families who are planning to move out of state within the six-month period\n* children with systemic health issues as classified by American Society of Anesthesiology Classification of greater than or equal to 3, or a mental health condition such as autism\u002Fdevelopmental delay, as medical complexity is associated with other issues that influence a child's health behaviors and caregiver-child interactions\n* and adults unable to consent.","7 Years",{"count":59,"type":23},420,"INTERVENTIONAL",[62],"NA","Too many young children, particularly those living in poverty, present for dental surgery under anesthesia - an expensive, potentially dangerous, short-term fix that often results in recurring oral health disease and subsequent surgeries. Dr. Helen Lee, an anesthesiologist, and Dr. Joanna Buscemi, a clinical health psychologist, recognized that to decrease need for surgeries, caregivers need resources and support to build their skills and knowledge around managing their child's oral health. After 5 years of relationship-building, publishing preliminary qualitative work, and building a team with the appropriate skills and knowledge, investigators developed a grant application to develop and test a parenting intervention for caregivers of preschool- aged children presenting for dental surgery.\n\nWith support from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH), the team created the PROTECT intervention with a focus on providing caregivers with parenting and behavioral tools to help improve tooth brushing and lower added sugar intake while simultaneously addressing social determinants of health that make behavior change more difficult. Community health workers will engage with caregivers for 6 months following the child's surgery to deliver PROTECT and support parents in behavioral change. A surgical event is a unique opportunity to change behaviors in systemically oppressed families that have manifested a need for behavior change. This intervention will meet caregivers needs at a critical time when risk disease recurrence intersects with a desire to change. This work has the potential to not only improve oral health of entire households but may also have a concomitant effect on parallel diseases, such as pediatric obesity.",[29],[29,66,67],"Behavioral Intervention","Community Health Workers","2026-05-07",{"date":70,"type":40},"2026-05-08",{"date":72,"type":40},"2025-09-30",{"date":74,"type":23},"2028-09",{"name":76,"class":47},"University of Illinois at Chicago",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":18,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":60,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":48},"100633214","vertical-dimension-changes-after-bioflx-vs-stainless-steel-crowns-in-primary-molars-100633214","NCT07523776","Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars","Vertical Dimension Changes and Mean Biting Force Following Bioflx Placement Over Pulp-treated Primary Molars Versus Stainless Steel Crowns: A Randomized Controlled Trial.","BIOFLX-SSC-RCT","Inclusion Criteria:\n\n* Pulp-treated primary molars (pulpotomy)\n\n  * Asymptomatic teeth after pulp therapy with no signs of infection, mobility, or radiographic pathology, such as internal resorption or periapical lesions\n  * Age 6 years to 9 years\n  * Male or female\n  * Cooperative child with positive Frankl behavior rating\n  * No missing teeth\n  * Normal occlusion, including normal overjet and overbite\n  * Free from systemic disease to allow continuity of follow-up\n\nExclusion Criteria:\n\n* Medically compromised or uncooperative children\n\n  * Tooth indicated for extraction because of root resorption, teeth near exfoliation, or deep subgingival caries that prevents proper coronal seal\n  * Teeth with more than two-thirds root resorption\n  * Previous pulp therapy\n  * Parafunctional habits, including bruxism, thumb-sucking, or other habits that may affect occlusal force measurements\n  * Inability to attend follow-up visits or parental refusal to participate","6 Years","9 Years",{"count":88,"type":23},18,[62],"this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.",[29,92,93],"Dental Caries","Pulp-Treated Primary Molars",[95,96,97,98,99],"Bioflx Crown","Stainless Steel Crown","Pulpotomy","Pediatric Dentistry","T-Scan","NOT_YET_RECRUITING","2026-04-06",{"date":103,"type":40},"2026-04-13",{"date":105,"type":23},"2026-04",{"date":107,"type":23},"2026-08",{"name":109,"class":47},"Cairo University",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":17,"sex":18,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":60,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":48},"100460179","phase-2-povidone-iodine-efficacy-study-100460179","NCT05272254","Povidone Iodine Efficacy Study","PIES","Inclusion Criteria:\n\n* Provide signed and dated informed consent\u002Fpermission form\n* Parents\u002Fprimary caregivers willing to comply with all study procedures and be available for the duration of the study\n* Male or female, of any race, ethnicity, aged 24 to 71 months and their parents\u002Fprimary caregivers who are 18 years of age or older or emancipated minors\n* In good general health as evidenced by medical history, per PI, and in compliance with current CDC, NYS Department of Health and URMC COVID-19 guidelines. American Society of Anesthesiologists (ASA) categories will be used; children classified as ASA I and ASA II will be eligible for the study.\n* Diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room (OR). A diagnosis of S-ECC will be based on the definition in accordance with American Academy of Pediatric Dentistry (AAPD)\n\nExclusion Criteria:\n\n* Having a known allergy or sensitivity to iodine or seafood, red or yellow food coloring, or to tea, including a hypersensitivity to fluoride varnish, or having thyroid disease, as determined by medical history\n* Receiving or having received treatment with another investigational drug within 30 days of the baseline visit (V1)","24 Months","71 Months",{"count":120,"type":23},202,[122],"PHASE2","This is a single center, randomized, double-blind, placebo-controlled Phase II clinical trial (RCT) to evaluate the efficacy of topical 10% Polyvinylpyrrolidone-Iodine (PVPI) to prevent new caries lesions when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). At baseline, following oral rehabilitation in the operating room {10% (PVPI + Fluoride Varnish (FV)} will be compared to the current standard of care (Placebo + FV). Study participants will be followed for approximately 24 months post-baseline. The study interventions post-baseline will be administered at 3, 6, 9, 12, 15, 18, and 21 months.",[29],"2026-02-24",{"date":127,"type":40},"2026-02-27",{"date":129,"type":40},"2022-09-15",{"date":131,"type":23},"2027-05",{"name":133,"class":47},"University of Rochester",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":60,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100621947","study-of-obstacles-and-barriers-to-changing-risky-eating-behaviors-in-families-of-children-with-severe-early-childhood-caries-qualikids-100621947","NCT07377240","Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (QUALIKIDS).","Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (SECC): a Qualitative Approach (QUALIKIDS)","QUALIKIDS","Inclusion Criteria:\n\n* All parents of children under 6 years of age with CPE-S, consulting the specialized dental care unit as part of the Handiconsult ARA Ouest program for complete conservative oral rehabilitation under general anesthesia\n* Verbal agreement from the participant to take part in the study and for audio recording\n* Parents who understand and speak French.\n\nExclusion Criteria:\n\n* Parents of children in foster care.\n* Parents under judicial protection, guardianship, or conservatorship.\n* Parents who refuse to participate in the study.",{"count":143,"type":23},30,[62],"Dental caries is the most common chronic disease in children, and its early form-Early Childhood Caries (ECC)-which particularly affects children under the age of six, represents a major public health problem worldwide. This disease has a negative impact on the quality of life of affected children and their families, and leads to significant functional and developmental consequences. Moreover, due to their young age, these children require specialized care and adapted treatment procedures, particularly the use of general anesthesia (GA) for comprehensive oral rehabilitation.\n\nThis conservative therapeutic approach improves the quality of life and orofacial functions of the children concerned, particularly their masticatory ability. However, there remains a significant rate of caries recurrence within the year following treatment. This is largely due to the difficulty families face in changing the dietary habits that contribute to the disease, such as the frequent consumption of sugar-rich foods in all their forms. These families are often bio-psycho-socially vulnerable and have a low level of oral health literacy. They also tend to show lower adherence to preventive measures (oral hygiene practices and regular dental check-ups for children) as well as to the health education and therapeutic interventions proposed to them.\n\nIn order to stabilize dental caries in these children, prevent repeated procedures due to recurrent caries, and offer interventions tailored to their needs, it is essential to better understand why oral health behaviors are so difficult to change within these families. This study aims to adopt a qualitative approach to explore the obstacles and barriers to modifying etiological behaviors, particularly dietary behaviors, in families of young children with severe ECC treated under general anesthesia in the specialized care unit of Handiconsult ARA Ouest (CHU Estaing Clermont-Ferrand - CH Riom). Semi-structured, face-to-face interviews conducted with one or both parents will investigate the different dimensions of this issue. A subgroup analysis will compare the factors influencing the adoption of oral health-promoting habits in families of children with and without associated developmental disorders.",[29],"2026-01-29",{"date":149,"type":40},"2026-02-02",{"date":151,"type":23},"2026-01",{"date":153,"type":23},"2028-07",{"name":155,"class":47},"University Hospital, Clermont-Ferrand",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":18,"minAge":117,"maxAge":118,"enrollmentInfo":164,"targetDuration":4,"studyType":60,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":48},"100576567","effectiveness-and-acceptability-of-sdf-compared-to-art-for-the-management-of-early-childhood-caries-100576567","NCT06786975","Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries","EFFECTIVENESS, ACCEPTABILITY AND ORAL HEALTH-RELATED QUALITY OF LIFE OF SILVER DIAMINE FLUORIDE COMPARED TO ATRAUMATIC RESTORATIVE TREATMENT FOR THE MANAGEMENT OF EARLY CHILDHOOD CARIES: PROTOCOL OF A PRAGMATIC RANDOMIZED CLINICAL TRIAL","SDF and ART","Inclusion Criteria:\n\n* Children belonging to INTEGRA or JUNJI kindergarten, from 2 years up to 5 years and 11 months with informed consent signed by parents and assent from the child.\n* Children with at least one active cavitated caries lesion, extended in dentin with no signs of pulp involvement and diagnosed with ICDAS code 5.\n\nExclusion Criteria:\n\n* Children with underlying systemic disease or disability\n* Children with known allergies to dental materials used\n* Children with transitory residence\n* Children with severe alterations of the dental estructure",{"count":165,"type":23},156,[62],"The goal of this clinical trial is to assess the acceptability and clinical effectiveness of Silver Diamine Fluoride (SDF) in comparison with Atraumatic Restorative Treatment (ART) in Early Childhood Caries (ECC) management at the community level. The main question it aims to answer are:\n\n• It's SDF more accepted and effective than ART in early childhood caries management when implemented at the community level?\n\nParticipants will be diagnosed by an experienced and calibrated dentist using the International Caries Detection and Assessment System (ICDAS), then children with decayed teeth will be treated with SDF (experimental) or ART (control); another operator will choose randomly the treatment for each participant. Furthermore, oral health education component will be given to children, parents and educators.\n\nFollow-up visits will be made at 6 and 12 months after child's treatment is complete. Before and after treatment parents will be asked to complete a child personal background survey (before), Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire (before and at follow-ups) and a oral health satisfaction survey (one week after treatment and at follow-ups). The acceptability will be assessed through quantitative and qualitative methods.\n\nResearchers will compare the SDF's groups and the ART's group to see which of them is more accepted and effective.",[29,169],"Health Care Acceptability",[29,171,172],"Silver Diamine Fluoride","Atraumatic Restorative Treatment","2025-12-04",{"date":175,"type":40},"2025-12-12",{"date":177,"type":23},"2025-12-15",{"date":179,"type":23},"2027-02-28",{"name":181,"class":47},"Universidad de La Frontera"]