Actively Recruiting

Age: 9Months - 24Months
All Genders
Healthy Volunteers
ID05761197

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

Led by Temple University · Updated on 2025-07-14

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Temple University

Lead Sponsor

C

Children's Hospital of Philadelphia

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand the relationship between early Candida infection, known as oral thrush or oropharyngeal candidiasis (OPC), in infants during their first year and the development and severity of severe early childhood caries (S-ECC). The study will explore how OPC may influence the plaque microbiota and contribute to early dental disease in young children. The study will enroll 70 infants aged 9 to 15 months, divided equally between those with a history of OPC and those without, matched by age and sex. Participants will be observed over multiple visits at baseline, 6, 12, 18, and 24 months. During these visits, oral exams and dental plaque or oral swab samples will be collected alongside surveys about demographics, oral hygiene, diet, delivery, feeding methods, and medication use. Throughout the study, researchers will review medical and dental history, perform soft tissue and caries exams, and collect data on oral microbiota changes. The main focus is to assess the onset and severity of S-ECC over 24 months and examine the influence of OPC on oral microbial communities. Parent or guardian consent and ongoing participation over two years are required for comprehensive monitoring and data collection.

CONDITIONS

Brief Title

Oropharyngeal Candidiasis (OPC) and S-ECC

Who Can Participate

Age: 9Months - 24Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female individuals aged 9 to 24 months
  • Must have at least one fully erupted tooth at baseline visit
  • Parent or guardian willing and able to provide informed consent
  • Participants with or without a history of oropharyngeal candidiasis (OPC)
Not Eligible

You will not qualify if you...

  • Presence of systemic medical conditions such as Down syndrome
  • Presence of an orofacial deformity
  • Presence of dental caries at baseline
  • Use of systemic antimicrobial therapy within 30 days before baseline visit
  • Any condition that the investigator believes makes participation not in the individual's best interest

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 24 months

Participants undergo oral examinations and sample collections to observe the association of early oral thrush with the onset and severity of severe early childhood caries.

5 visits (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups)

Trial Site Locations

Total: 1 location

1

Temple University

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

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Research Team

Y

Yuan Liu, DDS, MS, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors.

N J Kassebaum, A G C Smith, E Bernabé...

https://pubmed.ncbi.nlm.nih.gov/28792274

Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.

GBD 2016 Disease and Injury Incidence and Prevalence Collaborators

https://pubmed.ncbi.nlm.nih.gov/28919117

Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies.

American Academy on Pediatric Dentistry, American Academy of Pediatrics

https://pubmed.ncbi.nlm.nih.gov/19216381

Presence of mutans streptococci and Candida spp. in dental plaque/dentine of carious teeth and early childhood caries.

Fabíola Galbiatti de Carvalho, Danilo Souza Silva, Josimeri Hebling...

https://pubmed.ncbi.nlm.nih.gov/16890907

Genotypic distribution of Candida albicans in dental biofilm of Chinese children associated with severe early childhood caries.

Xiao Qiong Yang, Qiong Zhang, Li Ying Lu...

https://pubmed.ncbi.nlm.nih.gov/22717324

Genotypic diversity and cariogenicity of Candida albicans from children with early childhood caries and caries-free children.

Rongmin Qiu, Wenqing Li, Yan Lin...

https://pubmed.ncbi.nlm.nih.gov/26576955