Association Between Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)
Led by Temple University · Updated on 2025-07-14
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T
Temple University
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand the relationship between early Candida infection, known as oral thrush or oropharyngeal candidiasis (OPC), in infants during their first year and the development and severity of severe early childhood caries (S-ECC). The study will explore how OPC may influence the plaque microbiota and contribute to early dental disease in young children.
The study will enroll 70 infants aged 9 to 15 months, divided equally between those with a history of OPC and those without, matched by age and sex. Participants will be observed over multiple visits at baseline, 6, 12, 18, and 24 months. During these visits, oral exams and dental plaque or oral swab samples will be collected alongside surveys about demographics, oral hygiene, diet, delivery, feeding methods, and medication use.
Throughout the study, researchers will review medical and dental history, perform soft tissue and caries exams, and collect data on oral microbiota changes. The main focus is to assess the onset and severity of S-ECC over 24 months and examine the influence of OPC on oral microbial communities. Parent or guardian consent and ongoing participation over two years are required for comprehensive monitoring and data collection.
CONDITIONS
Brief Title
Oropharyngeal Candidiasis (OPC) and S-ECC
Who Can Participate
Age: 9Months - 24Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Male or female individuals aged 9 to 24 months
Must have at least one fully erupted tooth at baseline visit
Parent or guardian willing and able to provide informed consent
Participants with or without a history of oropharyngeal candidiasis (OPC)
You will not qualify if you...
Presence of systemic medical conditions such as Down syndrome
Presence of an orofacial deformity
Presence of dental caries at baseline
Use of systemic antimicrobial therapy within 30 days before baseline visit
Any condition that the investigator believes makes participation not in the individual's best interest
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 24 months
Participants undergo oral examinations and sample collections to observe the association of early oral thrush with the onset and severity of severe early childhood caries.
5 visits (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups)
Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors.
Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators