Early oral thrush and baby tooth decay
Association Between Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)
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 type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 9 Months to 24 Months |
| Sex | All |
| Sponsor | Temple University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05761197 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.