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: 8523830
• 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/8523830
• 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，尤其是在低收入和处境不利的人群中。在美国境外进行的几项临床试验的结果（尚未进行美国研究）表明，在简化和经济程序中使用的玻璃离子体水泥（GIC）修复体（GIC）的修复体被称为荒谬的修复治疗（ART）技术，可能比用于增加恢复寿命的大量恢复寿命和减少的经常性疾病可能比传统的牙科治疗更成功。尚未明确建立艺术成功的原因，但有人建议GIC可能与受影响的组织相互作用以恢复其矿物质的一部分。当细菌牙齿与消耗的可消耗的可发酵碳水化合物结合在一起时，就会发生龋齿。这种组合产生的酸会穿透并溶解牙齿表面。 GIC是具有低技术敏感性和释放氟化物（F）的生物相容性材料，从而产生了龋齿病变的内部回忆。艺术是一种“漫画”技术，因为不需要牙齿或麻醉，因此在某些情况和情况下使其有利。汞齐是一种汞合金，牙医传统上用另一种金属（银）填充牙齿的空腔。在AIM 1中，我们计划对最初有5至11岁的儿童进行前瞻性队列研究，其中至少有一个Carious原发性磨牙（1至3个表面被塌陷），该研究已通过ART或ARALGAM恢复。儿童，加利福尼亚州奥克兰的亚洲卫生服务诊所的患者以及主要是旧金山西班牙裔宣教社区的牙科诊所，将获得最初的牙科评估，包括治疗前X光片，以及员工牙医的治疗。两家诊所都同意参与并使用两种材料作为通常护理的一部分。招募适合儿童和牙齿选择标准的患者。将对ART和AMALGAM修复体的基线临床和放射线照相评估，以及6个月和12个月的随访评估（无X光片）进行评估：a）龋齿复发，b）恢复性保留率，c）随着时间的推移，恢复率恢复了边际完整性。在目标2和3中，将使用在研究期间自然剥落角质的牙齿进行两种修复材料的分析。在AIM 2中，我们将检查机械性能，修复/牙齿界面的微观结构特性（纳米识别和SEM-EDS），以鉴定通过恢复材料在组织中诱导的变化，并为可能引起此类变化的机制提供洞察力。在AIM 3中，我们将评估修复/牙齿界面（RMS）的化学变化，以确定牙科材料（GIC和汞齐）与牙科组织（搪瓷和牙本质）的相互作用引起的回忆化的存在。更好地理解这两种材料的临床，机械和化学特性的相似性和差异，将在原牙中放置时，将有助于指导未来在美国使用的建议。 公共卫生相关性：这项临床转化观察性研究将使我们能够评估两种牙齿修复材料在两个较低社会经济地位家庭的高龋齿危孩子中的有效性，其中许多人依靠公共援助。在加利福尼亚州奥克兰的亚洲卫生服务诊所（AHSDC），另一名人口接受治疗，另一个人口在加利福尼亚州旧金山的Mission Shooligher的中美洲资源中心（Carecen）牙科诊所接受治疗。这项研究将促进我们对漫画恢复治疗（ART）与传统汞合金技术的临床结果的理解。艺术具有低成本，相对易于应用，尤其是对幼儿的优势，而不需要麻醉和牙齿钻孔。另外，将在去角质后收集修复的牙齿，以检查回忆过程以及机械和化学特性。如果结果有利于恢复保留，边际完整性，龋齿复发，回想起以及与牙科组织的其他相互作用的艺术有利，则这种治疗可能会影响牙科实践，患者管理政策和公共卫生。