Oropharyngeal Candidiasis (OPC) and S-ECC

Study Overview
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Brief Summary
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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
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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 60 infants (aged 6-15-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.

Official Title
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Association of Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)

Conditions
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Candida Infection, Oral Thrush, Early Childhood Caries

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female individuals at the age of 6-15-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 30 participants with and 30 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with history of OPC<br>Individuals in the non-OPC cohort will be age and sex-matched to individuals in the OPC cohort. | |
| Children without history of OPC<br>Individuals in the OPC cohort will be age and sex-matched to individuals in the non-OPC cohort. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the influence of OPC on the oral microbiota | Microbiome profiling will be done by shot gun sequencing | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral candidiasis, Candida infection, Oral thrush, Early childhood caries, Oral Health