Validation of chair-side biochemical screening instruments for dental caries

描述（由申请人提供）：长期以来，人们已经认识到需要开发一种用于龋齿活动和龋齿风险的准确的椅旁筛查仪器，并且在该领域进行了广泛的研究工作，但没有取得太大成功。我们的研究为解决这一问题提供了一种新的方法。这种方法是建立在一个新的模型，龋齿风险金字塔（CRP），它总结了现有的知识有关的龋齿生物学。假设：基于CRP模型，我们假设测量牙菌斑和/或唾液从尿素或其他唾液基质产生碱的能力，以及从糖产生酸的能力，可以提供对个体龋齿状态和可能的未来龋齿风险的准确估计，因为它们总结了其他龋齿风险因素的综合影响。目的：为了验证这一假设，我们开发了一系列新颖的椅旁测试，用于测量牙菌斑和唾液中的酸碱生成。本研究的目的是评估这些测试的可靠性和有效性作为筛查工具的龋齿，并探讨可能的方法，结合这些测试的结果，以准确地识别个人与龋齿。为了实现这一目标，建议对200名成人受试者进行横断面研究。重要性：所提出的测试是新颖的，因为他们认为在菌斑中产生碱的能力是一个潜在的龋齿风险因素，这是以前没有包括在现有的多变量风险评估模型。与现有的生物龋齿风险测试相比，它们成本低，结果更快。它们不需要牙科专业知识，这使得它们适合非牙科专业人士使用。一旦这些测试在成人中得到验证，我们的最终目标是在儿童和婴儿中验证它们作为早期儿童龋齿（ECC）的筛查工具，并最终作为未来龋齿风险的预测因子，无论是独立的，还是与其他龋齿风险因素相结合。所提出的测试的另一个重要的潜在应用将是在临床牙科实践、研究和社区干预中比较干预前后的风险。 公共卫生相关性：在美国，龋齿影响超过50%的儿童（5至9岁）和84%的成年人，它对健康，生活质量和经济产生重大影响。龋齿的患病率在某些少数民族人口和社会经济地位低的个人中较高，因此，该疾病被认为是一个重要的健康差距。有趣的是，虽然美国龋齿的患病率在过去30年中一直在缓慢下降，但在最年轻的年龄组（2至5岁）中并未观察到这种下降。这些事实表明，目前可用于龋齿预防和管理的一般措施并不适用于所有人，需要识别和解决高危人群中的新风险因素。 拟议的研究是重要的，因为它解决了这一重要问题。这项研究的目的是验证一种新的方法，用于识别患有龋齿或在不久的将来有患龋齿风险的人。这种方法由一系列可以在椅旁执行的简单测试组成。该方法的创新之处在于，这些测试测量了现有龋齿风险评估模型中先前未考虑的风险因素。与现有的龋齿风险测试相比，所提出的测试的优点是低成本和更快的结果。更重要的是，它们不需要任何牙科专业知识，这使得它们适合非牙科专业人士使用。 一旦这些测试在成人中得到验证，我们的最终目标是在儿童和婴儿中验证它们作为早期儿童龋齿（ECC）的筛查工具，并最终作为未来龋齿风险的预测因子，无论是独立的，还是与其他龋齿风险因素相结合。儿科医生和学校护士可以使用它们来识别处于发展ECC的直接风险的婴儿和幼儿，以及由外行公共和卫生专业人员来识别高龋齿风险个体并将他们转介给牙医进行适当的治疗。此外，拟议的测试可用于评估预防和临床干预措施的有效性，在私人牙科诊所，在研究中，并在社区干预，通过比较龋齿的风险之前和之后的干预。

DESCRIPTION (provided by applicant): The need to develop an accurate chair-side screening instrument for caries activity and caries risk has been long recognized and extensive research work has been done in this area without much success. Our study takes a new approach in solving this problem. This approach is founded on a novel model, the Caries Risk Pyramid (CRP), which summarizes the available knowledge regarding the biology of dental caries. HYPOTHESIS: Based on the CRP model, we hypothesize that measuring the ability of dental plaque and/or saliva to generate alkali from urea, or other salivary substrates, together with the ability to generate acid from sugars, can provide an accurate estimation of an individual's caries status and possibly future caries risk because they summarize the combined effect of other caries risk factors. OBJECTIVE: In order to test this hypothesis we have developed an array of novel, chair-side tests for measuring acid and alkali generation in plaque and in saliva. The objective of this study is to assess the reliability and validity of these tests as screening tools for dental caries and to explore possible ways of combining the results of these tests in order to accurately identify individuals with caries. To accomplish this objective, a cross-sectional study on 200 adult subjects is proposed. SIGNIFICANCE: The proposed tests are novel because they consider the ability to generate alkali in plaque as a potential caries risk factor, which has not been previously included in existing multivariate risk assessment models. They are of low cost and give faster results compared to available biological caries risk tests. They do not require dental expertise, which makes them suitable for use by non-dental professionals. Once the tests have been validated in adults, our ultimate goal is to validate them in children and infants as screening tools for Early Childhood Caries (ECC), and ultimately as a predictor of future caries risk, either independently, or in combination with other caries risk factors. Another important potential application for the proposed tests would be the comparison of pre- to post- intervention risk in clinical dental practice, in research, and in community interventions. PUBLIC HEALTH RELEVANCE: Dental caries affects more than 50% of the children (ages 5 to 9 years) and 84% of the adults in the USA and it has a significant impact on the health, quality of life, and on the economy. The prevalence of dental caries is higher in certain ethnic minority populations and in individuals of low socioeconomic status and for that reason the disease is considered as an important health disparity. Interestingly, while the prevalence of dental caries has been declining slowly over the past thirty years in the United States, this decline has not been observed in the youngest age groups, those of 2 to 5 years. These facts demonstrate that the generalized measures currently available for caries prevention and management are not effective for all individuals and that there is a need to identify and address novel risk factors in high-risk populations. The proposed study is significant because it addresses this important issue. The objective of the study is to validate a new method for identifying individuals who have dental caries, or who are at risk to develop caries in the near future. This method consists of an array of simple tests that can be performed chair-side. The innovation of the method is that these tests measure risk factors that have not been previously considered in the existing caries risk assessment models. The advantages of the proposed tests are low cost and much faster results compared to available caries risk tests. More importantly, they do not require any dental expertise, which makes them suitable for use by non-dental professionals. Once the tests have been validated in adults, our ultimate goal is to validate them in children and infants as screening tools for Early Childhood Caries (ECC), and ultimately as a predictor of future caries risk, either independently, or in combination with other caries risk factors. They could be used by pediatricians and school nurses to identify infants and small children at an immediate risk to develop ECC, as well as by lay public and health professionals to identify high caries risk individuals and refer them to dentists for appropriate treatment. In addition, the proposed tests could be used for evaluating the effectiveness of preventive and clinical interventions in private dental practice, in research, and in community interventions, by comparing caries risk before and after the interventions.