Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT05761197

Conditions

Candida Infection

Oral Thrush

Early Childhood Caries

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Study Details

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).

Conditions

Candida Infection

Oral Thrush

Early Childhood Caries

Study ID

NCT05761197

Start date

Sep 1, 2024

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

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

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • To explore the association between OPC and S-ECC onset and severity [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Yuan Liu, DDS, MS, PhD

215-707-8029yuan.liu0008@temple.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Yuan Liu, DDS, MS, PhD

215-707-8029ksodtres@temple.edu

More Information

Sponsor

Temple University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Oral candidiasis
  • Candida infection
  • Oral thrush
  • Early childhood caries
  • Oral Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2026-06-22.