Improving Clinical Outcomes for Severe Early Childhood Caries

描述（由申请人提供）：此R34临床试验计划拨款申请是为了支持II期随机试验的组织。我们计划进行一项单中心（罗切斯特）随机、双盲、安慰剂对照的II期试验（RCT），以评价在一次手术治疗的S-ECC（严重-早期儿童龋齿）儿童中外用PI的初步疗效。所有受试者将随访2年或直至复发，以较早者为准。参与者主要来自少数民族社区，将被随机分配至2种干预措施之一（N=140）：1）局部PI 4次/年+ADA定义的社区标准治疗（氟化物保护漆（FV）4次/年+OHI+关于促进进食行为的咨询）或2）局部安慰剂4次/年+社区标准治疗。结果测量将是涉及牙本质的龋损（代码5，国际龋评估和检测系统（IDCAS））。幼儿龋齿（ECC）是一个日益严重的公共卫生问题，最常影响社会经济地位较低群体的幼儿。S-ECC是ECC的最具破坏性的形式，在世界范围内已达到接近流行的程度。S-ECC的特征在于变形链球菌（MS）的压倒性感染挑战和腐烂促进摄食行为。S-ECC的护理标准包括龋齿的修复和拔除、局部氟化物的应用、口腔卫生说明（OHI）和关于喂养行为的建议（口腔健康政策，参考手册，Amer Acad of Pediatr Dent，2005）。牙科手术对口腔MS储库的影响最小，关于喂养习惯的咨询成功率非常有限。毫不奇怪，S-ECC治疗的临床结果很差;早期的临床结果研究表明，大约40%接受S-ECC治疗的儿童在牙科手术后1年内会出现新的龋损。最近，ADA建议S-ECC儿童每年至少使用两次氟化物保护漆（FV），理想情况下每年使用4次;然而，最近的论文清楚地表明，即使多次和密集的氟化物治疗也不能阻止高危人群的蛀牙，这些儿童继续经历广泛的新蛀牙。S-ECC的临床结局可能会通过不对卫生资源造成财政负担的治疗方式来实现，并侧重于这种疾病的感染方面。用局部抗菌剂抑制口腔MS储库是一种潜在的方法。在这方面，10%聚维酮碘（PI）被批准用于儿科口服，并在S-ECC背景下对口服MS储库具有抑制作用。该提案设计的意义有两个方面：1）它将生成关于接受FV季度治疗的S-ECC儿童中新龋齿病变的患病率和发生率的数据，这对于计划III期试验将是有价值的，2）它将填补我们对高龋齿风险儿童单独使用FV和与PI联合使用的疗效的知识空白。 公共卫生相关性：严重幼儿龋齿（S-ECC）是一种传染病，仍然是一个重大的全球公共卫生问题，最常影响社会经济地位较低群体的幼儿，并已达到流行病的程度。S-ECC治疗的临床结果很差;大约40%的S-ECC治疗儿童在牙科手术后12个月内会形成新的蛀牙。S-ECC的临床结局改善可能通过不对卫生资源造成财政负担的干预措施来实现。该提案将评估使用防腐剂和氟化物保护漆的联合治疗改善S-ECC临床结局的疗效。

DESCRIPTION (provided by applicant): This R34 Clinical Trial Planning grant application is to support the organization of a phase II randomized trial. We propose to conduct a single center (Rochester) randomized, double-blind placebo-controlled Phase II trial (RCT) to evaluate the preliminary efficacy of topical PI given to children with S-ECC (Severe-Early Childhood Caries) who have been surgically treated in one session. All participants will be followed for 2 years or until relapse, whichever is sooner. Participants, largely drawn from the minority community, will be randomized to one of 2 interventions (N=140): 1) topical PI 4 times/year plus the community standard of care as defined by the ADA (fluoride varnish (FV) 4 times/year +OHI+ counseling regarding decay promoting feeding behaviors or 2) topical placebo 4 times/year plus the community standard of care. The outcome measure will be carious lesions with dentin involvement (Code 5, International Caries Assessment and Detection System (IDCAS). Early Childhood Caries, (ECC) is a growing public health problem that afflicts young children most often in lower socioeconomic groups. S-ECC is the most damaging form of ECC and has reached near epidemic proportions worldwide. S-ECC is characterized by an overwhelming infectious challenge by mutans streptococci (MS) and decay promoting feeding behaviors. The standard of care for S-ECC includes restoration and extraction of carious teeth, application of topical fluoride, oral hygiene instructions (OHI) and recommendations regarding feeding behaviors (Oral Health Policies, Reference Manual, Amer Acad of Pediatr Dent, 2005). Dental surgery has minimal impact on oral MS reservoirs and counseling regarding feeding habits has had very limited success. Not surprisingly, clinical outcomes for treatment of S-ECC are poor; earlier clinical outcomes studies demonstrate that approximately 40% of children treated for S-ECC will develop new carious lesions within 1 year post dental surgery. Recently, the ADA recommended fluoride varnish (FV) at least twice per year and ideally 4 times per year for children with S-ECC; however, recent papers demonstrate clearly than even multiple and intensive fluoride treatments do not arrest tooth decay in high risk populations and such children continue to experience extensive new decay,. Improved clinical outcomes for S-ECC will likely be realized through treatment modalities that are not a financial burden on health resources and focus on the infectious aspect of this disease. Suppressing oral MS reservoirs with a topical anti-microbial agent is a potential approach. In this regard, 10% povidone iodine (PI) is approved for pediatric oral use and has suppressive effects on oral MS reservoirs in the setting of S-ECC. The significance of the proposal's design is twofold: 1) it will generate data on the prevalence and incidence of new caries lesions in children treated for S- ECC receiving quarterly treatment with FV, which will be valuable for planning a Phase III trial and 2) it will fill an important gap in our knowledge on the efficacy of FV alone and in combination with PI for high caries risk children. PUBLIC HEALTH RELEVANCE: Severe Early Childhood Caries (S-ECC) is an infectious disease that continues to be a significant global public health problem that afflicts young children most often in lower socioeconomic groups and has reached epidemic proportions. Clinical results for treatment of S-ECC are poor; approximately 40% of children treated for S-ECC will develop new cavities within 12 months after dental surgery. Improved clinical outcomes for S- ECC will likely be realized through interventions that are not a financial burden on health resources. This proposal will assess the efficacy of a combined therapy using an antiseptic and a fluoride varnish for improving clinical outcomes for S-ECC.