EFFICACY OF IMPLANT SUPPORTED DENTURES IN DIABETICS

种植体支持的假牙在糖尿病患者中的功效

• 批准号: 3222881
• 负责人: KRISHAN K KAPUR
• 金额: $ 14.16万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-03-01 至 1995-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3222881
• 关键词: biomaterial compatibility; blood chemistry; blood glucose; dental occlusion; dentures; electromyography; endosseous dental implant; glycosylation; hemoglobin As; human subject; insulin dependent diabetes mellitus; jaw movement; mastication; noninsulin dependent diabetes mellitus; nutrient intake activity; nutrition related tag; oral health; questionnaires; satisfaction; taste threshold

The primary purpose of this study will be to determine whether an overlay mandibular denture supported by osseointegrated dental implants is an effective treatment alternative to a conventional complete denture in diabetic patients whose metabolic biochemical control is achieved primarily either by dietary therapy, which may be supplemented by oral hypoglycemic agents, or by insulin. The effectiveness of the two types of dentures would be based upon improvements in denture comfort, masticatory efficiency, food selection, dietary intake, quality of life, patient satisfaction and cost of initial and maintenance care. One hundred and eight elderly male diabetic patients with acceptable metabolic control will be randomly assigned to four groups providing two control groups, one with 24 insulin treated (IT) and the other with 24 non-insulin treated (NIT) patients and two experimental groups, one with 30 IT and the other with 30 NIT patients. Patients in the control groups will receive a new set of maxillary and mandibular dentures and in the experimental groups a new maxillary denture and an overlay mandibular denture supported by two osseointegrated implants. They will be followed in the Diabetic Clinic on a quarterly basis for glycosylated hemoglobin concentrations and in the Dental Clinic for observation and oral hygiene instructions. In addition, they will be instructed to monitor their fasting glucose levels at least three times a week. A series of clinical evaluations and subjective and objective measurements will be made immediately after entry into the study and at 6-month and 36-month intervals after the insertion of new dentures. Three sets of questionnaires (food preference, patient treatment evaluation and patient satisfaction) will be administered to determine perceived changes in mastication, speech, odor, denture hygiene, comfort, security and psychological well-being. The objective measurements will include salivary secretion rates, tactile discrimination thresholds, maximal biting pressures, oral clearance tests, and masticatory performance tests, electromyographic activity and mandibular movement recordings. A one-week dietary log will be kept to determine changes in food consumption patterns in terms of the degree of difficulty to chew foods. Comparisons between the two treatment groups will be made on the differences in percentages of treatment failures based on prespecified criteria as well as differences in the mean scores for each of the subjective and objective variables.

这项研究的主要目的将是确定覆盖是否 骨性种植体支持的下颌义齿是一种 传统全口义齿的有效替代治疗 代谢生化控制初步达到的糖尿病患者 要么通过饮食治疗，要么辅以口服降糖 药物，或通过胰岛素。这两种假牙的有效性将是 基于假牙舒适性、咀嚼效率、食物的改善 选择、饮食摄入量、生活质量、患者满意度和成本 初始护理和维护护理。 108例老年男性糖尿病患者可接受 代谢控制组将随机分配到四个小组，提供两个 对照组，一组接受24次胰岛素治疗(IT)，另一组24次 非胰岛素治疗(NIT)患者和两个实验组，一个组30人 它和另一组有30名NIT患者。对照组的患者将 接受一套新的上颌和下颌义齿，并在 试验组上颌新义齿与下颌覆盖义齿 由两个骨整合种植体支撑的义齿。 他们将在糖尿病诊所每季度进行一次跟踪调查 糖化血红蛋白浓度及其在牙科临床的应用 观察和口腔卫生说明。此外，他们将被 被指示监测他们的空腹血糖水平至少三次 星期。一系列临床评价及主客观 测量将在进入研究后立即进行，并在 新义齿植入后间隔6个月和36个月。三 成套问卷(食物偏好、患者治疗评估和 患者满意度)将用于确定感知到的变化 在咀嚼、言语、气味、假牙卫生、舒适性、安全性和 心理健康。客观的测量将包括唾液。 分泌率、触觉辨别阈值、最大咬合度 压力，口腔清洁测试，和咀嚼性能测试， 肌电活动和下颌运动记录。为期一周 将保存饮食记录，以确定食物消费模式的变化 就咀嚼食物的难易程度而言。 两个治疗组之间的比较将在 基于预先指定的治疗失败率的差异 标准以及每一项平均分数的差异 主客观变量。