Oropharyngeal Candidiasis (OPC) and S-ECC

Not yet recruiting

• Conditions: Candida Infection; Oral Thrush; Early Childhood Caries

• Registration Number: NCT05761197
• Lead Sponsor: University of Pennsylvania

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25
• Study Start: 2024-09-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To explore the association between OPC and S-ECC onset and severity	24 months	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the influence of OPC on the oral microbiota	24 months	Microbiome profiling will be done by shot gun sequencing

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States