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: 3222880
• 负责人: KRISHAN K KAPUR
• 金额: $ 13.74万
• 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/3222880
• 关键词: 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是确定是否覆盖 骨整合牙科植入物支持的下颌义齿是 有效的治疗替代方案是常规完整义齿 代谢生化对照的糖尿病患者主要实现 通过饮食疗法，可以通过口服降血糖补充 特工或通过胰岛素。两种义齿的有效性将 基于义齿舒适，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 初始和维护护理。 一百八名老年男性糖尿病患者可接受 代谢控制将随机分配给四组，提供两个 对照组，一个接受24个胰岛素治疗（IT），另一个胰岛素治疗为24 未经胰岛素治疗（NIT）患者和两个实验组，一组为30例 它和另一位患有30名NIT患者。对照组中的患者将 收到一套新的上颌和下颌义齿，并在 实验组新的上颌义齿和下颌覆盖 义齿由两个骨整合植入物支持。 他们将季度在糖尿病诊所进行遵循 糖基化的血红蛋白浓度和牙科诊所的 观察和口腔卫生说明。另外，他们将 指示监测其禁食葡萄糖水平至少三倍 星期。一系列临床评估以及主观和客观 进入研究后，将立即进行测量 插入新假牙后的6个月和36个月的间隔。三 问卷集（食物偏好，患者治疗评估和 患者满意度）将被给予确定感知的变化 在咀嚼，言语，气味，义齿卫生，舒适，安全和 心理健康。客观测量将包括唾液 分泌率，触觉歧视阈值，最大咬人 压力，口腔清除测试和咀嚼性能测试， 肌电图和下颌运动记录。一周 将保留饮食日志以确定食物消耗方式的变化 就咀嚼食物的困难程度而言。 将在两个治疗组之间进行比较 基于预先指定的治疗失败百分比的差异 每个标准以及平均得分的差异 主观和客观变量。