Improving Clinical Outcomes for Severe Early Childhood Caries

描述(由申请人提供)：本R34临床试验计划拨款申请是为了支持第二阶段随机试验的组织。我们建议进行一项单中心(罗彻斯特)随机、双盲、安慰剂对照的II期试验，以评估局部PI对在一次疗程中接受手术治疗的儿童S早期重度龋病的初步疗效。所有参与者将被跟踪2年或直到复发，以较早者为准。参与者主要来自少数族裔社区，他们将被随机分成2种干预措施(N=140)之一：1)局部PI 4次/年+ADA定义的社区护理标准(氟化物清漆(FV)4次/年+OHI+关于腐烂促进喂养行为的咨询；2)局部安慰剂4次/年+社区护理标准。结果衡量标准将是有牙本质参与的龋损(代码5，国际龋齿评估和检测系统(IDCAS)。早期儿童龋病(ECC)是一个日益严重的公共卫生问题，最常困扰较低社会经济群体的幼儿。S-ECC是最具破坏性的ECC形式，已在世界范围内达到接近流行的比例。S-ECC的特点是具有压倒性的感染挑战，包括变形链球菌(MS)和促进腐烂的摄食行为。S儿童牙周病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)和有关喂养行为的建议(口腔卫生政策，参考手册，儿科Amer Acad，2005)。牙科手术对口腔多发性硬化症宿主的影响微乎其微，有关进食习惯的咨询也收效甚微。不足为奇的是，治疗S-ECC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治疗的儿童将在牙科手术后一年内出现新的龋损。最近，美国食品和药物管理局建议S-ECC儿童每年至少服用两次氟化物清漆(FV)，理想情况下每年4次；然而，最近的论文清楚地表明，即使多次强化氟化物治疗也不能阻止高危人群的龋齿，这些儿童继续经历广泛的新的龋齿。改善S-ECC的临床结果可能会通过不对卫生资源造成经济负担并专注于这种疾病的感染方面的治疗方式来实现。使用局部抗菌剂抑制口服多发性硬化症储存库是一种潜在的方法。在这方面，10%聚维酮碘(PI)被批准用于儿童口服，并在S-ECC环境下对口腔MS储备库具有抑制作用。该建议设计的意义有两个：1)它将产生接受S-ECC治疗的儿童每季度接受FV治疗的新龋病患病率和发病率的数据，这将对计划III期试验非常有价值；2)它将填补我们对单独使用FV和联合PI治疗高龋齿儿童疗效的一个重要空白。 公共卫生意义：儿童早期严重龋病(S)是一种传染性疾病，它仍然是一个重大的全球公共卫生问题，最常困扰较低社会经济群体的幼儿，并已达到流行的程度。治疗S-ECC的临床效果很差；大约40%的接受治疗的S-ECC的儿童会在牙科手术后12个月内形成新的龋齿。改善S-ECC的临床结果可能会通过不对卫生资源造成经济负担的干预措施来实现。这项建议将评估使用防腐剂和氟化物清漆的联合治疗对改善S-ECC临床结果的有效性。

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.