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

July 11, 2025 updated by: Temple University

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

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria:

  • Male or female individuals at the age of 9-24-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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children with history of OPC
Individuals in the non-OPC cohort will be age and sex-matched to individuals in the OPC cohort.
Children without history of OPC
Individuals in the OPC cohort will be age and sex-matched to individuals in the non-OPC cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the association between OPC and S-ECC onset and severity
Time Frame: 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.
24 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study the role of Candida on biofilm cariogenic properties
Time Frame: 24 months
Candida-bacterial interaction in modulating biofilm development and virulence will be evaluated using validated experimental models
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Yuan Liu, DDS, MS, PhD, Temple University Kornberg School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31690

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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