NCT05761197

Oropharyngeal Candidiasis (OPC) and S-ECC

Association Between Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 9 Months – 24 Months
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Candida Infection
• Oral Thrush
• Early Childhood Caries

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2023-03-09
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States