Oropharyngeal Candidiasis (OPC) and S-ECC (Oral-Thrush)

Temple University

Status

Not yet enrolling

Conditions

Candida Infection

Oral Thrush

Early Childhood Caries

Study type

Observational

Funder types

Other

Identifiers

NCT05761197

31690

Details and patient eligibility

About

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).

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

9 to 15 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female individuals at the age of 9-15-month-old
Must have at least one fully erupted tooth at baseline visit
Parent/guardian willing and able to provide informed consent
With or without a history of OPC (the study team will enroll 35 participants with and 35 participants without a history of OPC)

Exclusion criteria

Presence of a systemic medical condition (e.g. Down syndrome etc.)
Presence of an orofacial deformity
Presence of dental caries
Use of systemic antimicrobial therapy within 30 days of the baseline visit
Presence of any condition which, in the opinion of the investigator, makes participation in the project not in the individual's best interest.