Prospective evaluation of immediate temporized implants

即刻临时种植体的前瞻性评估

• 批准号: 7237361
• 负责人: MICHAEL Steven BLOCK
• 金额: $ 19.48万
• 依托单位: LSU HEALTH SCIENCES CENTER
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-07 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7237361
• 关键词: All Sites; Anatomy; Anterior; Apical; Bone remodeling; Calculi; Clinic; Clinical Trials; Clinical Trials Design; Complex; Control Groups; Data; Dental crowns; Depth; End Point; Esthetics; Evaluation; Face; Gingiva; Goals; Healed; Health; Hemorrhage; Implant; Implantation procedure; Incisor; Inflammation; Inflammatory; Location; Maxilla; Measurement; Measures; Methods; Monitor; Movement; Oral cavity; Organ Transplantation; Outcome Measure; Papillary; Patients; Pattern; Personal Satisfaction; Placement; Plant Roots; Positioning Attribute; Procedures; Process; Questionnaires; Schools; Site; Staging; Stents; Time; Tissue Grafts; Tissues; Tooth Extraction; Tooth structure; Width; bone; bone loss; digital; follow-up; functional restoration; healing; indexing; prevent; prospective; restoration; satisfaction; soft tissue; success; tongue papilla

DESCRIPTION (provided by applicant): This revised application is a clinical trial designed to evaluate crestal bone level changes when implants are placed into extraction sites and immediately provisionalized. Extraction of maxillary incisor teeth is a common procedure as documented in our school clinics. Traditional treatment when a tooth is extracted includes a period of healing followed by placement of an implant. Our preliminary data indicates that the delayed approach results in labial bone loss with resultant horizontal deficiency in over 50% of cases, requiring hard and soft tissue grafting to achieve a functional result. Additional preliminary data indicates that grafting the extraction site and/or immediate implant placement and provisionalization results in a functional restoration, without the need for additional adjunctive grafting procedures. It is unclear how the crestal bone levels change during healing of the extraction site prior to implant placement, in contrast to immediate implant placement, with immediate provisionalization with a crown. We hypothesize that there will be differences in the crestal bone levels (primary endpoint), and differences in soft tissue levels and indices (secondary endpoints) between implants immediately temporized, placed either delayed or immediately after tooth extraction, with more bone loss in the immediate placement group (experimental) compared to the delayed placement group (control). The long-term goal is to determine if the crestal bone remodeling after tooth extraction or the apical position of the implant determines the final level of the crestal bone. Two groups of 45 patients will be evaluated. All subjects will have a single rooted maxillary tooth extracted. One group will have the socket grafted with mineralized bone and allowed four months prior to implant placement. The crestal bone in this group will have remodeled during the four months of healing prior to implant placement. The second group will have the implant placed immediately after tooth extraction, thus the crestal bone will remodel in the presence of the implant and the immediately placed temporary restoration, as a one-stage procedure. For both groups, the implants will be immediately temporized with a crown after implant placement. Standardized hard and soft tissue data will be collected preextraction as baseline, and then prospectively for at least two years in this trial, to compare and contrast the methods.

描述（由申请人提供）：本修订后的申请是一项临床试验，旨在评估将种植体放入拔牙部位并立即临时修复时牙槽嵴骨水平的变化。拔除上颌切牙是我们学校诊所记录的常见手术。拔牙时的传统治疗包括一段愈合期，然后植入种植体。我们的初步数据表明，超过 50% 的病例延迟入路会导致唇骨丢失并导致水平缺陷，需要硬组织和软组织移植才能达到功能性结果。额外的初步数据表明，移植拔牙部位和/或立即种植体植入和临时修复可实现功能恢复，而不需要额外的辅助移植手术。目前尚不清楚种植体植入前拔牙部位愈合期间牙槽嵴骨水平如何变化，与立即种植体植入（即用牙冠进行临时修复）相比。我们假设，在拔牙后立即临时放置、延迟放置或拔牙后立即放置的种植体之间，牙槽嵴骨水平（主要终点）以及软组织水平和指数（次要终点）存在差异，与延迟放置组（对照组）相比，立即放置组（实验）的骨丢失更多。长期目标是确定拔牙后牙槽嵴骨的重塑或种植体的根尖位置是否决定牙槽嵴骨的最终水平。将对两组 45 名患者进行评估。所有受试者都将拔除一颗上颌单根牙。一组将在牙槽窝上移植矿化骨，并在种植体植入前四个月进行。 该组的牙槽嵴骨将在种植体植入前四个月的愈合过程中进行重塑。第二组将在拔牙后立即放置种植体，因此牙槽嵴骨将在种植体存在的情况下重塑并立即放置临时修复体，作为一阶段手术。对于这两组患者，种植体植入后将立即用牙冠临时固定种植体。将在提取前收集标准化的硬组织和软组织数据作为基线，然后在该试验中前瞻性地收集至少两年，以比较和对比这些方法。