Improving Clinical Outcomes for Severe Early Childhood Caries

描述（由申请人提供）：这份R34临床试验计划拨款申请是为了支持组织一项II期随机试验。我们建议进行一项单中心（Rochester）随机、双盲、安慰剂对照的II期试验（RCT），以评估局部PI对接受过一次手术治疗的S-ECC（严重早期儿童龋齿）儿童的初步疗效。所有参与者将被随访2年或直到复发，以较早者为准。参与者主要来自少数民族社区，将被随机分配到两种干预措施中的一种（N=140）： 1)每年4次局部PI加上ADA定义的社区护理标准（氟化漆（FV）每年4次+OHI+关于促进喂养行为的蛀牙咨询）或2)每年4次局部安慰剂加上社区护理标准。结果测量将是牙本质受累的龋齿病变（代码5，国际龋齿评估和检测系统（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的幼儿。S-ECC是最具破坏性的ECC形式，在世界范围内已达到接近流行病的程度。S-ECC的特点是变形链球菌（MS）的压倒性感染挑战和腐烂促进摄食行为。S-ECC的护理标准包括修复和拔牙，局部氟化物的应用，口腔卫生指导（OHI）和关于喂养行为的建议（口腔卫生政策，参考手册，美国儿科学会，2005年）。牙科手术对口腔MS储存库的影响很小，关于饮食习惯的咨询也非常有限。毫不奇怪，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治疗的儿童在牙科手术后1年内会出现新的龋齿病变。最近，美国儿科协会建议氟化清漆（FV）每年至少两次，理想情况下每年4次对儿童的S-ECC；然而，最近的论文清楚地表明，在高危人群中，即使多次和强化氟化物治疗也不能阻止蛀牙，这些儿童继续经历广泛的新蛀牙。改善S-ECC的临床结果可能会通过不给卫生资源带来财政负担并侧重于该疾病的感染方面的治疗方式来实现。用局部抗微生物剂抑制口服质谱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环境下对口服MS库具有抑制作用。该提案设计的意义有两方面：1)它将产生关于接受FV季度治疗的S- ECC儿童新龋病患病率和发病率的数据，这将对规划III期试验有价值；2)它将填补我们对FV单独和PI联合治疗高龋风险儿童的有效性的知识的重要空白。

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.