Early Childhood Caries

6

Review clinical trials related to Early Childhood Caries. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Oropharyngeal Candidiasis (OPC) and S-ECC

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).

Participants needed: 70
Trial details
Age: 9-15Biological sex: AllType: ObservationalSponsor: Temple UniversityUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Male or female individuals at the age of 9-15-month-old [+3]

Presence of a systemic medical condition (e.g. Down syndrome etc.) [+4]

Status: Recruiting

Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery

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. With 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.

Participants needed: 420
Trial details
Age: Up to 7Biological sex: AllType: InterventionalSponsor: University of Illinois at ChicagoUpdated: May 8, 2026Locations: 1
Eligibility criteria

caregivers of child patients who are in the same household greater than or equal... [+3]

surgical child is foster status [+3]

Status: Not yet recruiting

Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars

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.

Participants needed: 18
Trial details
Age: 6-9Biological sex: AllType: InterventionalSponsor: Cairo UniversityUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Pulp-treated primary molars (pulpotomy) [+7]

Medically compromised or uncooperative children [+5]

Status: Recruiting

Povidone Iodine Efficacy Study

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.

Participants needed: 202
Trial details
Phase: Phase 2Age: 24-71Biological sex: AllType: InterventionalSponsor: University of RochesterUpdated: Feb 27, 2026Locations: 1
Eligibility criteria

Provide signed and dated informed consent/permission form [+4]

Having a known allergy or sensitivity to iodine or seafood, red or yellow food c... [+1]

Status: Not yet recruiting

Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (QUALIKIDS).

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. This 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. In 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.

Participants needed: 30
Trial details
Biological sex: AllType: InterventionalSponsor: University Hospital, Clermont-FerrandUpdated: Feb 2, 2026Locations: 1
Eligibility criteria

All parents of children under 6 years of age with CPE-S, consulting the speciali... [+2]

Parents of children in foster care. [+2]

Status: Not yet recruiting

Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries

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: • It's SDF more accepted and effective than ART in early childhood caries management when implemented at the community level? Participants 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. Follow-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. Researchers will compare the SDF's groups and the ART's group to see which of them is more accepted and effective.

Participants needed: 156
Trial details
Age: 24-71Biological sex: AllType: InterventionalSponsor: Universidad de La FronteraUpdated: Dec 12, 2025Locations: 1
Eligibility criteria

Children belonging to INTEGRA or JUNJI kindergarten, from 2 years up to 5 years... [+1]

Children with underlying systemic disease or disability [+3]