MANDIBULAR BONE MINERAL DENSITY

下颌骨矿物质密度

• 批准号: 6349068
• 负责人: Nancy E Lane
• 金额: $ 19.17万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6349068
• 关键词: alendronate; bone density; bone development; clinical research; clinical trials; combination chemotherapy; dental alveolus; dental disorder chemotherapy; dental radiography; female; genetic susceptibility; hormone therapy; human subject; human therapy evaluation; mandible /maxilla; osteopenia; parathyroid hormones; periodontitis

Adult periodontitis is a chronic inflammatory disease of bacterial etiology that results in alveolar bone loss. It has been reported recently that alveolar bone mass is reduced in women who have adult periodontitis. In addition, individuals with spinal osteoporosis have low mandibular bone mass compared to normal women. Studies in animals and humans have shown that the bisphosphonate, alendronate, can prevent bone loss by inhibiting osteoclast-mediated bone resorption and may also reduce local and systemic levels of inflammatory cytokines and some new bone formation. However, bisphosphonates and other therapies do not return bone mass to normal. However, bisphosphonates and other therapies do not return bone mass to normal. Administration by daily infection of parathyroid hormone (hPTH 1-34) has been found to stimulate new bone formation in patients. The goal of the present study is to restore lost bone in adult patients with severe periodontitis and low mandibular bone mass. The hypothesis underlying this study are: (1) that two years of bisphosphonate administration in conjunction with conventional periodontal therapy will lead to significantly greater new bone formation and gains in clinical attachment and alveolar bone height than conventional therapy alone, and that (2) in patients with bisphosphonate, the addition of hPTH (1-34) treatment, when used in conjunction with conventional periodontal treatment will significantly increase alveolar bone mass and may restore alveolar bone mass toward normal as compared to individuals treated with placebo and bisphosphonate. To test these hypotheses, a two-study will be conducted. In years 1-3, a 2-year randomized, placebo-controlled trial will be performed to determine if conventional periodontal therapy plus bisphosphonate will promote gains in clinical attachment and alveolar bone height in patients with adult periodontitis and low mandibular bone mass. In phase two (years 3-4), the bisphosphonate treatment group will be re-randomized to either hPTH (1-34) or placebo to determine whether addition of hPTH further restores bone mass and clinical attachment levels. Secondary outcomes include determining whether there is an association about specific IL-1 genotype and responsiveness to treatments.

成人牙周炎是一种慢性炎症性疾病的细菌病因，导致牙槽骨损失。据报道，最近牙槽骨质量减少的妇女谁有成人牙周炎。此外，与正常女性相比，脊柱骨质疏松症患者的下颌骨骨量较低。在动物和人类中的研究表明，双膦酸盐，阿仑膦酸盐，可以通过抑制破骨细胞介导的骨吸收来防止骨丢失，也可以降低局部和全身炎症细胞因子和一些新骨形成的水平。然而，双膦酸盐和其他疗法不能使骨量恢复正常。然而，双膦酸盐和其他疗法不能使骨量恢复正常。已发现通过每日感染甲状旁腺激素（hPTH 1-34）的施用刺激患者的新骨形成。本研究的目的是恢复严重牙周炎和下颌骨骨量低的成年患者的骨丢失。本研究的基本假设是：（1）与常规牙周治疗相结合的两年双膦酸盐给药将导致比单独常规治疗显著更大的新骨形成和临床附着和牙槽骨高度的增加，以及（2）在双膦酸盐患者中，增加hPTH（1-34）治疗，当与常规牙周治疗联合使用时，与用安慰剂和双膦酸盐治疗的个体相比，将显著增加牙槽骨质量，并可使牙槽骨质量恢复正常。为了验证这些假设，将进行两项研究。在第1-3年，将进行一项为期2年的随机、安慰剂对照试验，以确定常规牙周治疗加双膦酸盐是否能促进成人牙周炎和下颌骨骨量低患者的临床附着和牙槽骨高度的增加。在第二阶段（3-4年），双膦酸盐治疗组将重新随机分配至hPTH（1- 3 - 4）或安慰剂组，以确定添加hPTH是否进一步恢复骨量和临床附着水平。次要结果包括确定特定IL-1基因型与治疗反应性是否相关。