An observational study in Candida Infection, Oral Thrush and Early Childhood Caries, sponsored by Temple University. Recruiting at 1 site in United States. Open to participants aged 9 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Temple University · 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).
The overall goal of this study is to conduct a longitudinal observational study to investigate the association of early OPC with the onset and severity of S-ECC to better understand the role of Candida (particularly C. albicans) in severe childhood caries. The investigators will test the hypothesis that OPC is associated with S-ECC by modifying the plaque microbiota and enhancing virulence in a manner that is conducive to the early development of the disease.
For this study, a total of 70 infants (aged 9-15-month-old) with or without a history of OPC in their first year of life will be enrolled, based on the inclusion and exclusion criteria. Subjects will have their medical/dental history reviewed from medical records. At each study visit (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups), an oral examination including soft tissue and caries exam will be performed by a calibrated evaluator. Dental plaque/oral swab samples will be collected at each study visit. In addition, a comprehensive survey including demographic status, oral hygiene, diet, delivery, and feeding method as well as current medication usage will also be collected.
48 studies on the registry are indexed under Candidiasis, Oral; 6 are open to participants now.
Browse Candidiasis, Oral studies →Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Compared within Candidiasis, Oral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Candidiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study team will recruit 70 subjects (35 subjects with a history of OPC and 35 subjects without a history of OPC) for this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals in the non-OPC cohort will be age and sex-matched to individuals in the OPC cohort.
Individuals in the OPC cohort will be age and sex-matched to individuals in the non-OPC cohort.
To explore the association between OPC and S-ECC onset and severity
Caries will be measured by ICDAS scoring system; Plaque and oral swab samples will be collected at each study visit (Baseline, 6-month, 12-month,18-month and 24-month follow-ups); Candida strains will be detected using culturing-dependent and -independent sequencing techniques.
Time frame: 24 months
To evaluate the influence of OPC on the oral microbiota
Microbiome profiling will be done by shot gun sequencing
Time frame: 24 months
To study the role of Candida on biofilm cariogenic properties
Candida-bacterial interaction in modulating biofilm development and virulence will be evaluated using validated experimental models
Time frame: 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Aug 2028, 47 months after the start.
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