Candida InfectionOral-ThrushNCT05761197
Oropharyngeal Candidiasis (OPC) and S-ECC
An observational study of Candida Infection and Oral Thrush, run by Temple University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Candida Infection, Oral Thrush, Early Childhood Caries
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study team will recruit 70 subjects (35 subjects with a history of OPC and 35 subjects without a history of OPC) for this study.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Yuan Liu, DDS, MS, PhD, 215-707-8029, ksodtres@temple.edu
About this study
Official title: Association Between Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)
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).
Read the detailed description
The overall goal of this study is to conduct a longitudinal observational study to investigate the association of early OPC with the onset and severity of S-ECC to better understand the role of Candida (particularly C. albicans) in severe childhood caries. The investigators will test the hypothesis that OPC is associated with S-ECC by modifying the plaque microbiota and enhancing virulence in a manner that is conducive to the early development of the disease.
For this study, a total of 70 infants (aged 9-15-month-old) with or without a history of OPC in their first year of life will be enrolled, based on the inclusion and exclusion criteria. Subjects will have their medical/dental history reviewed from medical records. At each study visit (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups), an oral examination including soft tissue and caries exam will be performed by a calibrated evaluator. Dental plaque/oral swab samples will be collected at each study visit. In addition, a comprehensive survey including demographic status, oral hygiene, diet, delivery, and feeding method as well as current medication usage will also be collected.
- Conditions
- Candida Infection, Oral Thrush, Early Childhood Caries
- Keywords
- Oral candidiasis, Candida infection, Oral thrush, Early childhood caries, Oral Health
- Medical subject headings
- Candidiasis, Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with history of OPC | Individuals in the non-OPC cohort will be age and sex-matched to individuals in the OPC cohort. | |
| Children without history of OPC | Individuals in the OPC cohort will be age and sex-matched to individuals in the non-OPC cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the association between OPC and S-ECC onset and severity
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.
Measured: 24 months
Secondary outcomes (1)
To evaluate the influence of OPC on the oral microbiota
Microbiome profiling will be done by shot gun sequencing
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Sep 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Candida InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Yuan Liu, DDS, MS, PhD, Principal investigator, Temple University Kornberg School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761197
- Sponsor's protocol ID
- 31690
- Acronym
- Oral-Thrush
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. 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. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
PubMed 28792274GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. 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. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
PubMed 28919117Hajishengallis E, Parsaei Y, Klein MI, Koo H. Advances in the microbial etiology and pathogenesis of early childhood caries. Mol Oral Microbiol. 2017 Feb;32(1):24-34. doi: 10.1111/omi.12152. Epub 2016 Feb 4.
PubMed 26714612Bowen WH, Burne RA, Wu H, Koo H. Oral Biofilms: Pathogens, Matrix, and Polymicrobial Interactions in Microenvironments. Trends Microbiol. 2018 Mar;26(3):229-242. doi: 10.1016/j.tim.2017.09.008. Epub 2017 Oct 30.
PubMed 29097091Hajishengallis E, Forrest CB, Koo H. Early Childhood Caries: Future Perspectives in Risk Assessment. JDR Clin Trans Res. 2016 Jul;1(2):110-111. doi: 10.1177/2380084416637577. Epub 2016 Mar 7. No abstract available.
PubMed 28879240American Academy on Pediatric Dentistry; American Academy of Pediatrics. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2008-2009;30(7 Suppl):40-3. No abstract available.
PubMed 19216381de Carvalho FG, Silva DS, Hebling J, Spolidorio LC, Spolidorio DM. Presence of mutans streptococci and Candida spp. in dental plaque/dentine of carious teeth and early childhood caries. Arch Oral Biol. 2006 Nov;51(11):1024-8. doi: 10.1016/j.archoralbio.2006.06.001. Epub 2006 Aug 7.
PubMed 16890907Raja M, Hannan A, Ali K. Association of oral candidal carriage with dental caries in children. Caries Res. 2010;44(3):272-6. doi: 10.1159/000314675. Epub 2010 May 27.
PubMed 20516688Yang XQ, Zhang Q, Lu LY, Yang R, Liu Y, Zou J. Genotypic distribution of Candida albicans in dental biofilm of Chinese children associated with severe early childhood caries. Arch Oral Biol. 2012 Aug;57(8):1048-53. doi: 10.1016/j.archoralbio.2012.05.012. Epub 2012 Jun 18.
PubMed 22717324Qiu R, Li W, Lin Y, Yu D, Zhao W. Genotypic diversity and cariogenicity of Candida albicans from children with early childhood caries and caries-free children. BMC Oral Health. 2015 Nov 17;15(1):144. doi: 10.1186/s12903-015-0134-3.
PubMed 26576955Xiao J, Moon Y, Li L, Rustchenko E, Wakabayashi H, Zhao X, Feng C, Gill SR, McLaren S, Malmstrom H, Ren Y, Quivey R, Koo H, Kopycka-Kedzierawski DT. Candida albicans Carriage in Children with Severe Early Childhood Caries (S-ECC) and Maternal Relatedness. PLoS One. 2016 Oct 14;11(10):e0164242. doi: 10.1371/journal.pone.0164242. eCollection 2016.
PubMed 27741258Duangthip D, D D. Early childhood caries and candida albicans. Evid Based Dent. 2018 Dec;19(4):100-101. doi: 10.1038/sj.ebd.6401337.
PubMed 30573860Xiao J, Huang X, Alkhers N, Alzamil H, Alzoubi S, Wu TT, Castillo DA, Campbell F, Davis J, Herzog K, Billings R, Kopycka-Kedzierawski DT, Hajishengallis E, Koo H. Candida albicans and Early Childhood Caries: A Systematic Review and Meta-Analysis. Caries Res. 2018;52(1-2):102-112. doi: 10.1159/000481833. Epub 2017 Dec 21.
PubMed 29262404Metwalli KH, Khan SA, Krom BP, Jabra-Rizk MA. Streptococcus mutans, Candida albicans, and the human mouth: a sticky situation. PLoS Pathog. 2013;9(10):e1003616. doi: 10.1371/journal.ppat.1003616. Epub 2013 Oct 17. No abstract available.
PubMed 24146611Koo H, Bowen WH. Candida albicans and Streptococcus mutans: a potential synergistic alliance to cause virulent tooth decay in children. Future Microbiol. 2014;9(12):1295-7. doi: 10.2217/fmb.14.92. No abstract available.
PubMed 25517895
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)
- ClinicalTrials.gov ID
- NCT05761197
- Acronym / sponsor ID
- Oral-Thrush / 31690
- Conditions
- Candida Infection, Oral Thrush, Early Childhood Caries
- Keywords
- Oral candidiasis, Candida infection, Oral thrush, Early childhood caries, Oral Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The overall goal of this study is to conduct a longitudinal observational study to investigate the association of early OPC with the onset and severity of S-ECC to better understand the role of Candida (particularly C. albicans) in severe childhood caries. The investigators will test the hypothesis that OPC is associated with S-ECC by modifying the plaque microbiota and enhancing virulence in a manner that is conducive to the early development of the disease.
For this study, a total of 70 infants (aged 9-15-month-old) with or without a history of OPC in their first year of life will be enrolled, based on the inclusion and exclusion criteria. Subjects will have their medical/dental history reviewed from medical records. At each study visit (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups), an oral examination including soft tissue and caries exam will be performed by a calibrated evaluator. Dental plaque/oral swab samples will be collected at each study visit. In addition, a comprehensive survey including demographic status, oral hygiene, diet, delivery, and feeding method as well as current medication usage will also be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with history of OPC | – | –Individuals in the non-OPC cohort will be age and sex-matched to individuals in the OPC cohort. |
| Children without history of OPC | – | –Individuals in the OPC cohort will be age and sex-matched to individuals in the non-OPC cohort. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study team will recruit 70 subjects (35 subjects with a history of OPC and 35 subjects without a history of OPC) for this study.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To evaluate the influence of OPC on the oral microbiota
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 28792274Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. 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. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
- Background: PubMed 28919117GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. 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. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
- Background: PubMed 26714612Hajishengallis E, Parsaei Y, Klein MI, Koo H. Advances in the microbial etiology and pathogenesis of early childhood caries. Mol Oral Microbiol. 2017 Feb;32(1):24-34. doi: 10.1111/omi.12152. Epub 2016 Feb 4.
- Background: PubMed 29097091Bowen WH, Burne RA, Wu H, Koo H. Oral Biofilms: Pathogens, Matrix, and Polymicrobial Interactions in Microenvironments. Trends Microbiol. 2018 Mar;26(3):229-242. doi: 10.1016/j.tim.2017.09.008. Epub 2017 Oct 30.
- Background: PubMed 28879240Hajishengallis E, Forrest CB, Koo H. Early Childhood Caries: Future Perspectives in Risk Assessment. JDR Clin Trans Res. 2016 Jul;1(2):110-111. doi: 10.1177/2380084416637577. Epub 2016 Mar 7. No abstract available.
- Background: PubMed 19216381American Academy on Pediatric Dentistry; American Academy of Pediatrics. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2008-2009;30(7 Suppl):40-3. No abstract available.
- Background: PubMed 16890907de Carvalho FG, Silva DS, Hebling J, Spolidorio LC, Spolidorio DM. Presence of mutans streptococci and Candida spp. in dental plaque/dentine of carious teeth and early childhood caries. Arch Oral Biol. 2006 Nov;51(11):1024-8. doi: 10.1016/j.archoralbio.2006.06.001. Epub 2006 Aug 7.
- Background: PubMed 20516688Raja M, Hannan A, Ali K. Association of oral candidal carriage with dental caries in children. Caries Res. 2010;44(3):272-6. doi: 10.1159/000314675. Epub 2010 May 27.
- Background: PubMed 22717324Yang XQ, Zhang Q, Lu LY, Yang R, Liu Y, Zou J. Genotypic distribution of Candida albicans in dental biofilm of Chinese children associated with severe early childhood caries. Arch Oral Biol. 2012 Aug;57(8):1048-53. doi: 10.1016/j.archoralbio.2012.05.012. Epub 2012 Jun 18.
- Background: PubMed 26576955Qiu R, Li W, Lin Y, Yu D, Zhao W. Genotypic diversity and cariogenicity of Candida albicans from children with early childhood caries and caries-free children. BMC Oral Health. 2015 Nov 17;15(1):144. doi: 10.1186/s12903-015-0134-3.
- Background: PubMed 27741258Xiao J, Moon Y, Li L, Rustchenko E, Wakabayashi H, Zhao X, Feng C, Gill SR, McLaren S, Malmstrom H, Ren Y, Quivey R, Koo H, Kopycka-Kedzierawski DT. Candida albicans Carriage in Children with Severe Early Childhood Caries (S-ECC) and Maternal Relatedness. PLoS One. 2016 Oct 14;11(10):e0164242. doi: 10.1371/journal.pone.0164242. eCollection 2016.
- Background: PubMed 30573860Duangthip D, D D. Early childhood caries and candida albicans. Evid Based Dent. 2018 Dec;19(4):100-101. doi: 10.1038/sj.ebd.6401337.
- The Global Burden of Disease 2015 study aims to use all available data of sufficient quality to generate reliable and valid prevalence, incidence, and disability-adjusted life year (DALY) estimates of oral conditions for the period of 1990 to 2015.Link provided by the sponsor.
- As mortality rates decline, life expectancy increases, and populations age, non-fatal outcomes of diseases and injuries are becoming a larger component of the global burden of disease. The Global Burden of Diseases, Injuries, and Risk Factors Study 2016Link provided by the sponsor.
- This review provides a broader perspective about the etiology and pathogenesis of ECC based on previous and current knowledge on biofilm matrix, microbial diversityLink provided by the sponsor.
- The article discusses recent advances in the role of the biofilm matrix and interactions between opportunistic pathogens and commensals in the pathogenesis of dental caries.Link provided by the sponsor.
- Early identification and early application of preventive measures are essential to help eliminate this costly and painful diseaseLink provided by the sponsor.
- AAPD encourages healthcare providers and caregivers to implement preventive practices that can decrease a child's risks of developing this preventable disease to reduce the burden on the child, the family, and societyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuan Liu, DDS, MS, PhD principal investigator
Temple University Kornberg School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candida Infection and Oral Thrush, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Liu, DDS, MS, PhD (215-707-8029, yuan.liu0008@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the association between OPC and S-ECC onset and severity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761197, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.