NCT05761197 · Temple University
Oropharyngeal Candidiasis (OPC) and S-ECC
(Oral-Thrush)
What this study is about
The overall objective of this study is to investigate the association of early Candida infection (known as taken by mouth 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).
View original scientific description
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).
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Philadelphia, Pennsylvania
Collaborators
Children's Hospital of Philadelphia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations