Oropharyngeal Candidiasis (OPC) and S-ECC

ConditionsCandida Infection Oral Thrush Early Childhood Caries

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age9-15

SponsorTemple University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants

are grouped into 2 trial groups

Group A: Children with history of OPC

Group B: Children without history of OPC

Trial outcomes

Primary outcomes

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

Secondary outcomes

To evaluate the influence of OPC on the oral microbiota

Microbiome profiling will be done by shot gun sequencing

Time frame

24 months

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Temple University

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

Source ClinicalTrials.gov

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