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NCT Number: NCT05761197

Oropharyngeal Candidiasis (OPC) and 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).

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Key information

Age range

9 month–15 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location status: Recruiting

Location contact

Yuan Liu, DDS, MS, PhD

CONTACT

[email protected]

215-707-8029

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. To evaluate the influence of OPC on the oral microbiota

    Time frame: 24 months

    Microbiome profiling will be done by shot gun sequencing

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan Liu, DDS, MS, PhD

CONTACT

[email protected]

215-707-8029

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

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

Acronym: Oral-Thrush

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 9, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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