RecruitingNot Applicable

Oropharyngeal Candidiasis (OPC) and S-ECC

United States70 participantsStarted 2024-09-01

Plain-language 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).

Who can participate

Age range

9 Months – 15 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To explore the association between OPC and S-ECC onset and severity

Timeframe: 24 months

Trial details

NCT IDNCT05761197

SponsorTemple University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08-31

Contact for this trial

Yuan Liu, DDS, MS, PhD

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

View on ClinicalTrials.gov More Candida Infection trials

Who can participate

Age range

9 Months – 15 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.