Clinical , Mechanical and Chemical Evaluation of Amalgam and ART Restorations

汞合金和ART修复体的临床,机械和化学评估

• 批准号: 8330669
• 负责人: Lilliam Marie Pinzon
• 金额: $ 12.89万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8330669
• 关键词: 11 year old; Acids; Affect; Alloys; Anesthesia procedures; Asians; Biocompatible Materials; California; Carbohydrates; Central American; Characteristics; Chemicals; Chemistry; Child; Clinic; Clinical; Cohort Studies; Collection; Conduct Clinical Trials; Dental; Dental Clinics; Dental Enamel; Dental General Practice; Dental Materials; Dental Plaque; Dental caries; Dentin; Dentists; Disadvantaged; Economics; Effectiveness; Enrollment; Evaluation; Fluorides; Future; Glass Ionomer Cements; Hardness; Health Services; Hispanics; Histocompatibility Testing; Household; Incidence; International Health Problems; Lesion; Longevity; Low income; Measures; Mechanics; Mercury; Metals; Minerals; Mission; Molar tooth; Neighborhoods; Observational Study; Outcome; Participant; Patients; Policies; Population; Postoperative Period; Procedures; Process; Property; Protocols documentation; Public Assistance; Public Health; Recommendation; Recruitment Activity; Recurrence; Research; Resources; Risk; San Francisco; Scanning Electron Microscopy; Selection Criteria; Silver; Specimen; Surface; Tactile; Techniques; Time; Tissues; Tooth structure; Visual; chemical property; cost; deciduous tooth; follow-up; glass ionomer; insight; interfacial; low socioeconomic status; nanoindentation; prospective; public health relevance; remineralization; research clinical testing; restoration; restorative material; restorative treatment; success; tooth surface; treatment as usual

DESCRIPTION (provided by applicant): Dental caries (tooth decay) remains a significant national and international health problem, especially in low- income and disadvantaged populations. Results of several clinical trials conducted outside the US (US studies have not been conducted) have suggested that glass ionomer cement (GIC) restorations used in a simplified and economic procedure known as atraumatic restorative treatment (ART) technique may be more successful than conventional dental treatments for large carious lesions with respect to increased restoration longevity and decreased caries recurrence. The reasons for the success of ART have not been clearly established, but it has been suggested that the GIC may interact with the caries affected tissue to restore a portion of its mineral content. Dental caries occurs when bacterial dental plaque combines with consumed, fermentable carbohydrates. This combination produces acids that penetrate and dissolves the tooth surfaces. GIC's are biocompatible materials having low technique sensitivity and release fluoride (F) which creates internal remineralization of a carious lesion. ART is an "atraumatic" technique as no drilling of teeth or anesthesia is required, thus making it advantageous in certain settings and situations. Amalgam is an alloy of mercury with another metal (silver) used traditionally by dentists to fill cavities in teeth. In Aim 1, we plan to conduct a prospective cohort study of initially 5 to 11 year-old children with at least one carious primary molar (1 to 3 surfaces cavitated) that has been restored with ART or amalgam. The children, patients at the Asian Health Services Dental Clinic in Oakland, CA and the CARECEN dental clinic in the primarily Hispanic Mission neighborhood of San Francisco, will receive initial dental assessments including pre-treatment radiographs, and treatment by staff dentists. Both clinics have agreed to participate and use both materials as part of their usual care. Patients that fit the child and tooth-level selection criteria will be recruited. Baseline clinical and radiographic evaluation of the ART and amalgam restorations, and 6-month and 12-month follow-up assessments (without radiographs) will be take place to assess clinical outcomes: a) caries recurrence, b) restoration retention, and c) restoration marginal integrity over time. In aims 2 and 3, analyses of the two restorative materials will be undertaken with restored teeth that naturally exfoliate during the study period. In Aim 2 we will examine the mechanical properties, microstructural characteristics of the restoration/tooth interfaces (Nanoindentation, and SEM-EDS) to identify changes induced in the tissues by the restorative materials and to provide insight to the mechanisms that could induce such changes. In Aim 3 we will evaluate the chemical changes of the restoration/tooth interfaces (RMS) to identify the presence of remineralization caused by the interaction of the dental materials (GIC and amalgam) with the dental tissues (enamel and dentin). A better understanding of the similarities and differences in the clinical, mechanical and chemical properties of these two materials when placed in primary teeth will help guide future recommendations for their use in the US. Public Health Relevance: This clinical translational observational study will allow us to evaluate the effectiveness of two dental restorative materials in two populations of high caries-risk children from lower socio-economic status households, many of whom rely on public assistance. One population is treated at the Asian Health Services Dental Clinic (AHSDC) in Oakland, California and the other at the Central American Resource Center (CARECEN) dental clinic in primarily Hispanic, Mission Neighborhood of San Francisco, California. This research will advance our understanding of the clinical outcomes of atraumatic restorative treatment (ART) vs. traditional amalgam techniques. ART has the advantage of being low cost, relatively easy to apply, especially to young children, and not requiring anesthesia and drilling of teeth. Additionally, the restored teeth will be collected after exfoliation to examine the remineralization process, and mechanical and chemical properties. If the results are favorable for ART with regard to restoration retention, marginal integrity, decreased caries recurrence, remineralization and other interactions with dental tissues, this type of treatment has the potential to impact dental practice, patient management policies, and public health.

描述（由申请人提供）：龋齿（蛀牙）仍然是一个重大的国家和国际健康问题，特别是在低收入和弱势群体中。在美国境外进行的几项临床试验结果（尚未在美国进行研究）表明，在一种被称为无创修复治疗 (ART) 技术的简化且经济的程序中使用的玻璃离子水门汀 (GIC) 修复体，在延长修复体寿命和减少龋齿复发方面，可能比针对大型龋损的传统牙科治疗更成功。 ART 成功的原因尚未明确，但有人认为 GIC 可能与受龋齿影响的组织相互作用，以恢复其部分矿物质含量。当细菌牙菌斑与消耗的可发酵碳水化合物结合时，就会发生龋齿。这种组合产生的酸可以渗透并溶解牙齿表面。 GIC 是具有低技术敏感性的生物相容性材料，并释放氟化物 (F)，从而使龋齿病变内部再矿化。 ART 是一种“无创”技术，因为不需要钻孔或麻醉，因此在某些环境和情况下具有优势。汞合金是汞与另一种金属（银）的合金，传统上牙医使用它来填充牙齿中的蛀牙。在目标 1 中，我们计划对 5 至 11 岁的儿童进行一项前瞻性队列研究，这些儿童至少有一颗龋坏的乳磨牙（1 至 3 个表面有空洞），并已通过 ART 或汞合金修复。这些儿童是加利福尼亚州奥克兰亚洲健康服务牙科诊所和旧金山主要西班牙裔教会社区 CARECEN 牙科诊所的患者，他们将接受初步牙科评估，包括治疗前的 X 光片和牙医的治疗。两家诊所均同意参与并使用这两种材料作为其日常护理的一部分。将招募符合儿童和牙齿水平选择标准的患者。将进行 ART 和汞合金修复体的基线临床和放射学评估，以及 6 个月和 12 个月的随访评估（无放射线照片），以评估临床结果：a) 龋齿复发，b) 修复体保留，以及 c) 随着时间的推移修复体边缘完整性。在目标 2 和 3 中，将对研究期间自然脱落的修复牙齿进行两种修复材料的分析。在目标 2 中，我们将检查修复体/牙齿界面的机械性能、微观结构特征（纳米压痕和 SEM-EDS），以识别修复材料在组织中引起的变化，并深入了解可能引起此类变化的机制。在目标 3 中，我们将评估修复体/牙齿界面 (RMS) 的化学变化，以确定是否存在由牙科材料（GIC 和汞合金）与牙组织（牙釉质和牙本质）相互作用引起的再矿化。更好地了解这两种材料在放置于乳牙中时在临床、机械和化学特性方面的异同，将有助于指导未来在美国使用它们的建议。 公共卫生相关性：这项临床转化观察研究将使我们能够评估两种牙科修复材料对来自社会经济地位较低家庭的两组高龋齿风险儿童的有效性，其中许多家庭依赖公共援助。一组人群在加利福尼亚州奥克兰的亚洲健康服务牙科诊所 (AHSDC) 接受治疗，另一组人群在加利福尼亚州旧金山使命社区的中美洲资源中心 (CARECEN) 牙科诊所接受治疗，该诊所主要是西班牙裔美国人。这项研究将增进我们对无创恢复治疗 (ART) 与传统汞合金技术的临床结果的理解。 ART 的优点是成本低，相对容易应用，特别是对于幼儿，并且不需要麻醉和钻孔。此外，修复后的牙齿将在去角质后收集，以检查再矿化过程以及机械和化学特性。如果在修复体保留、边缘完整性、减少龋齿复发、再矿化以及与牙组织的其他相互作用方面的结果有利于 ART，则这种类型的治疗有可能影响牙科实践、患者管理政策和公共卫生。