Clinical trial Recruiting at 1 site Observational Ages 9 Months to 15 Months

Early oral thrush and baby tooth decay

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

Run by Temple University · NCT05761197 · Data updated 2026-11-12

This study will see if having oral thrush in the first year of life is linked to earlier or more severe tooth decay in infants and toddlers.

Quick facts

Study typeObservational
Ages9 Months to 15 Months
SexAll
Enrollment70 (estimated)
SponsorTemple University
Academic / other
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedSeptember 1, 2024
Main results expectedAugust 31, 2028
Study endsAugust 31, 2028
Registry record updatedJune 22, 2026
Trial IDNCT05761197 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants 9–24 months old with at least one erupted tooth whose parent or guardian can give informed consent and attend scheduled visits, whether or not they had oral thrush in their first year, are eligible.

Probably not a fit

Children who already have dental caries, have systemic medical conditions, or cannot attend in-person follow-ups are excluded and are unlikely to benefit directly from this study's preventive insights.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a longitudinal observational study enrolling 70 infants aged 9–24 months, with 35 participants who had oral thrush (OPC) in their first year and 35 who did not. Participants undergo a baseline visit and follow-ups at 6, 12, 18, and 24 months with calibrated oral exams, dental plaque and swab sampling, and detailed surveys about health, feeding, and oral care. Investigators will compare the plaque microbiota and clinical caries outcomes over time to test whether early Candida colonization promotes severe early childhood caries (S-ECC). No interventions are given; the study aims to clarify microbial and clinical links between OPC and S-ECC.

Why it matters

Potential benefit: If successful, the results could help identify infants at higher risk for severe early childhood caries so clinicians and families can focus prevention earlier.

How similar studies have gone: Prior laboratory and cross-sectional studies have suggested links between Candida (especially C. albicans) and caries, but prospective, longitudinal infant studies like this are limited, making the approach partially novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Temple University
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

  • Principal investigator: Yuan Liu, DDS, MS, PhD — Temple University Kornberg School of Dentistry
  • Study coordinator: Yuan Liu, DDS, MS, PhD
  • Email: yuan.liu0008@temple.edu
  • Phone: 215-707-8029

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.