口咽念珠菌病 (OPC) 和 S-ECC (Oral-Thrush)
2024年2月13日 更新者：University of Pennsylvania
早期念珠菌感染（鹅口疮）和严重儿童早期龋病 (S-ECC) 的关联
本研究的总体目标是调查儿童早期念珠菌感染（称为口腔鹅口疮或口咽念珠菌病，OPC）与严重幼儿龋齿 (S-ECC) 的发病和严重程度之间的关系。
研究概览
详细说明
本研究的总体目标是进行纵向观察研究，以调查早期 OPC 与 S-ECC 的发病和严重程度之间的关联，以更好地了解念珠菌（尤其是白色念珠菌）在严重儿童龋齿中的作用。 研究人员将通过改变斑块微生物群并以有利于疾病早期发展的方式增强毒力来检验 OPC 与 S-ECC 相关的假设。
对于这项研究，根据纳入和排除标准，总共将招募 60 名婴儿（6-15 个月大）在其生命的第一年有或没有 OPC 病史。 受试者将从医疗记录中审查他们的医疗/牙科病史。 在每次研究访问（基线、6 个月、12 个月、18 个月和 24 个月的随访）中，将由经过校准的评估员进行口腔检查，包括软组织和龋齿检查。 将在每次研究访视时收集牙菌斑/口腔拭子样本。 此外，还将收集包括人口统计状况、口腔卫生、饮食、分娩和喂养方法以及当前药物使用情况在内的综合调查。
研究类型
观察性的
注册 (估计的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yuan Liu, DDS, MS, PhD
- 电话号码：215-573-6248
- 邮箱：liuyuan1@upenn.edu
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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副研究员：
- Eugene Ko, DDS
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接触：
- Yuan Liu, PhD, DDS
- 电话号码：215-573-6248
- 邮箱：liuyuan1@upenn.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 1年 (孩子)
接受健康志愿者
是的
取样方法
概率样本
研究人群
研究团队将招募 60 名受试者（30 名有 OPC 病史的受试者和 30 名没有 OPC 病史的受试者）进行这项研究。
描述
纳入标准：
- 6-15个月大的男性或女性个体
- 在基线访问时必须至少有一颗完全萌出的牙齿
- 家长/监护人愿意并能够提供知情同意
- 有或没有 OPC 病史（研究小组将招募 30 名有 OPC 病史的参与者和 30 名没有 OPC 病史的参与者）
排除标准：
- 存在全身性疾病（例如 唐氏综合症等）
- 存在口面部畸形
- 龋齿的存在
- 基线访视后 30 天内使用全身抗微生物治疗
- 存在任何条件，调查人员认为，参与项目不符合个人的最佳利益。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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有 OPC 病史的儿童
非 OPC 队列中的个体将与 OPC 队列中的个体进行年龄和性别匹配。
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无 OPC 病史的儿童
OPC 队列中的个体将与非 OPC 队列中的个体进行年龄和性别匹配。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
探索 OPC 与 S-ECC 发病和严重程度之间的关联
大体时间：24个月
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龋齿将通过ICDAS评分系统进行测量；每次研究访视（基线、6 个月、12 个月、18 个月和 24 个月随访）时将收集牙菌斑和口腔拭子样本；念珠菌菌株将使用依赖于培养和独立于培养的测序技术进行检测。
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24个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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评估 OPC 对口腔微生物群的影响
大体时间：24个月
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微生物组分析将通过霰弹枪测序完成
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24个月
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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研究念珠菌对生物膜致龋特性的作用
大体时间：24个月
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将使用经过验证的实验模型评估念珠菌-细菌在调节生物膜发育和毒力方面的相互作用
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24个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yuan Liu, DDS, MS, PhD、Penn Dental School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.
- GBD 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. Erratum In: Lancet. 2017 Oct 28;390(10106):e38.
- American 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.
- Bowen 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.
- 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.
- Hajishengallis 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.
- Hajishengallis 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.
- de 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.
- Raja 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.
- Yang 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.
- Qiu 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.
- Xiao 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.
- Duangthip D, D D. Early childhood caries and candida albicans. Evid Based Dent. 2018 Dec;19(4):100-101. doi: 10.1038/sj.ebd.6401337. Erratum In: Evid Based Dent. 2019 Mar;20(1):13. D, Duangthip [corrected to Duangthip D].
- Xiao 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.
- Metwalli 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.
- Koo 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.
- Falsetta ML, Klein MI, Colonne PM, Scott-Anne K, Gregoire S, Pai CH, Gonzalez-Begne M, Watson G, Krysan DJ, Bowen WH, Koo H. Symbiotic relationship between Streptococcus mutans and Candida albicans synergizes virulence of plaque biofilms in vivo. Infect Immun. 2014 May;82(5):1968-81. doi: 10.1128/IAI.00087-14. Epub 2014 Feb 24.
- Hwang G, Liu Y, Kim D, Li Y, Krysan DJ, Koo H. Candida albicans mannans mediate Streptococcus mutans exoenzyme GtfB binding to modulate cross-kingdom biofilm development in vivo. PLoS Pathog. 2017 Jun 15;13(6):e1006407. doi: 10.1371/journal.ppat.1006407. eCollection 2017 Jun.
- Kim D, Sengupta A, Niepa TH, Lee BH, Weljie A, Freitas-Blanco VS, Murata RM, Stebe KJ, Lee D, Koo H. Candida albicans stimulates Streptococcus mutans microcolony development via cross-kingdom biofilm-derived metabolites. Sci Rep. 2017 Jan 30;7:41332. doi: 10.1038/srep41332.
- Koo H, Andes DR, Krysan DJ. Candida-streptococcal interactions in biofilm-associated oral diseases. PLoS Pathog. 2018 Dec 13;14(12):e1007342. doi: 10.1371/journal.ppat.1007342. eCollection 2018 Dec. No abstract available.
- Kim HE, Liu Y, Dhall A, Bawazir M, Koo H, Hwang G. Synergism of Streptococcus mutans and Candida albicans Reinforces Biofilm Maturation and Acidogenicity in Saliva: An In Vitro Study. Front Cell Infect Microbiol. 2021 Feb 19;10:623980. doi: 10.3389/fcimb.2020.623980. eCollection 2020.
- Jean J, Goldberg S, Khare R, Bailey LC, Forrest CB, Hajishengallis E, Koo H. Retrospective Analysis of Candida-related Conditions in Infancy and Early Childhood Caries. Pediatr Dent. 2018 Mar 15;40(2):131-135.
- Kressin NR, Nunn ME, Singh H, Orner MB, Pbert L, Hayes C, Culler C, Glicken SR, Palfrey S, Geltman PL, Cadoret C, Henshaw MM. Pediatric clinicians can help reduce rates of early childhood caries: effects of a practice based intervention. Med Care. 2009 Nov;47(11):1121-8. doi: 10.1097/MLR.0b013e3181b58867.
- Hedrick VE, Comber DL, Estabrooks PA, Savla J, Davy BM. The beverage intake questionnaire: determining initial validity and reliability. J Am Diet Assoc. 2010 Aug;110(8):1227-32. doi: 10.1016/j.jada.2010.05.005.
- Broffitt B, Levy SM, Warren J, Cavanaugh JE. Factors associated with surface-level caries incidence in children aged 9 to 13: the Iowa Fluoride Study. J Public Health Dent. 2013 Fall;73(4):304-10. doi: 10.1111/jphd.12028. Epub 2013 Jul 26.
- Shoaib L, Deery C, Ricketts DN, Nugent ZJ. Validity and reproducibility of ICDAS II in primary teeth. Caries Res. 2009;43(6):442-8. doi: 10.1159/000258551. Epub 2009 Nov 12.
- Policy on Early Childhood Caries (ECC): Classifications, Consequences, and Preventive Strategies. Pediatr Dent. 2016 Oct;38(6):52-54. No abstract available.
- Drury TF, Horowitz AM, Ismail AI, Maertens MP, Rozier RG, Selwitz RH. Diagnosing and reporting early childhood caries for research purposes. A report of a workshop sponsored by the National Institute of Dental and Craniofacial Research, the Health Resources and Services Administration, and the Health Care Financing Administration. J Public Health Dent. 1999 Summer;59(3):192-7. doi: 10.1111/j.1752-7325.1999.tb03268.x. No abstract available.
有用的网址
- 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.
- 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 2016
- This review provides a broader perspective about the etiology and pathogenesis of ECC based on previous and current knowledge on biofilm matrix, microbial diversity
- 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.
- Early identification and early application of preventive measures are essential to help eliminate this costly and painful disease
- 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 society
- This study determined the presence of mutans streptococci and Candida spp. in supragingival dental plaque and infected dentine of caries-free children, with early childhood caries and caries
- This study was carried out to identify association between oral candidal carriage in children and dental caries.
- In this study, the authors investigate the presence and genotypic distribution of C. albicans in the dental biofilm of Chinese children with severe early childhood caries (S-ECC).
- This study aimed to explore the genotypic diversity and cariogenicity of C. albicans from children with early childhood caries and caries-free children.
- The goal of this study was to examine the C. albicans carriage in children with severe early childhood caries (S-ECC) and the maternal relatedness.
- Children with oral C. albicans have higher odds of experiencing ECC, compared to children without C. albicans.
- This systematic review indicates that children with oral C. albicans have >5 times higher odds of having ECC compared to those without C. albicans.
- The presence of C. albicans in the oral environment can now be considered an additional factor that needs to be taken into account in evaluating risks to caries
- The authors suggest the need to explore how Candida infection is acquired and whether some strains are more infectious than others.
- Using a rodent model, the authors explored the implications of the cross-kingdom interaction for the pathogenesis of dental caries.
- Enhanced understanding of GtfB-Candida interactions may provide new perspectives for devising effective therapies to disrupt this cross-kingdom relationship associated with an important childhood oral disease.
- This study was conducted to investigate how microbial products from this cross-kingdom association modulate S. mutans build-up in biofilms.
- Clinical data, together with in vivo studies, provide compelling evidence of the importance of cross-kingdom interactions in the severity of mucosal diseases and dental caries.
- The authors provide feasible data to support the clinical findings in regards to the synergistic association between S. mutans and C. albicans in the pathogenesis of ECC.
- The purpose of this study was to assess whether there is an association between oral thrush or other Candida-related conditions in infancy and early childhood caries (ECC) diagnosed by pediatricians.
- Early childhood caries (ECC) is a serious and preventable disease which pediatric clinicians can help address by counseling to reduce risk.
- The purpose of this cross-sectional investigation was to determine the validity and reliability of a self-administered beverage intake questionnaire (BEVQ) that estimates mean daily intake of beverages consumed across 19 beverage categories.
- As dental caries can progress throughout a person's lifetime, understanding caries risk factors unique to specific life phases is important. This study aims to assess caries incidence and risk factors for young adolescents.
- The ICDAS criteria was developed by an international team of caries researchers to integrate several new criteria systems into one standard system for caries detection and assessment.
- The aim of this in vitro study was to assess the validity and reproducibility of the ICDAS II (International Caries Detection and Assessment System) criteria in primary teeth.
- The American Academy of Pediatric Dentistry (AAPD) encourages healthcare providers and caregivers to implement preventive practices that can decrease a child's risks of developing this disease.
- The workshop's goal was to review current methods of diagnosis of dental caries in primary teeth and to propose case definitions and diagnostic criteria for future research projects regarding dental caries in preschool-aged children.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2024年7月1日
初级完成 (估计的)
2028年8月31日
研究完成 (估计的)
2028年8月31日
研究注册日期
首次提交
2023年2月22日
首先提交符合 QC 标准的
2023年2月27日
首次发布 (实际的)
2023年3月9日
研究记录更新
最后更新发布 (实际的)
2024年2月14日
上次提交的符合 QC 标准的更新
2024年2月13日
最后验证
2024年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.