CENTER FOR NATIVE ORAL HEALTH RESEARCH (CNOHR) RESEARCH COMPONTENT 2 (RC2)

本土口腔健康研究中心 (CNOHR) 研究部分 2 (RC2)

• 批准号: 7950123
• 负责人: Robert J Genco
• 金额: $ 68.67万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950123
• 关键词: Address; American Indian and Alaska Native; American Indians; Blinded; Blood; Calculi; Clinical; Communities; Community Participation; Comorbidity; Control Groups; Data; Dental Clinics; Dental Plaque; Development; Diabetes Mellitus; Diagnosis; Drug Formulations; Effectiveness; Evaluation; Exclusion Criteria; FDA approved; Funding; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Goals; Government; Health; Health Knowledge, Attitudes, Practice; Health Services; Healthcare; Hemorrhage; Hydrochloride Salt; Individual; Investigation; Link; Measures; Mediator of activation protein; Minocycline; Non-Insulin-Dependent Diabetes Mellitus; Oral; Oral health; Outcome Measure; Participant; Patients; Periodontal Diseases; Periodontal Pocket; Periodontitis; Phase III Clinical Trials; Population; Procedures; Protocols documentation; Provider; Randomized; Randomized Clinical Trials; Recommendation; Recruitment Activity; Research; Research Design; Safety; Serious Adverse Event; Services; Severities; Shapes; Structure; Testing; Tooth Loss; Topical application; Treatment Effectiveness; Work; base; clinical practice; comparative efficacy; cost; cost effectiveness; design; diabetes control; diabetic; efficacy testing; eligible participant; evidence base; experience; health disparity; health related quality of life; primary outcome; programs; psychologic; response; scaling and root planing; secondary outcome; treatment site

The goal of RC2 is to evaluate the effectiveness of two approaches to treating periodontal disease in American Indians (Als) with diabetes. Both diabetes and periodontal disease (PD) are more than twice as common in AI/ANs than in the general U.S. population. When compared with other groups with diabetes, at least some groups of Als also experience disparities in the severity of PD. Finally, previous studies suggest that there are systemic links between the two conditions. The specific aims of this study will be: 1) to compare the efficacy of scaling and root planing (SRP) for reducing periodontal pocket depth in diabetics with scaling and root planing plus topical minocycline hydrochloride (SRP+), with both also compared to a delayed treatment control condition (TxD); 2) to compare the three treatment conditions on additional measures of PD; 3) to compare the three conditions on measures of glycated hemoglobin (HbA1c) and costeffectiveness; and 4) to assess safety and acceptability of the treatments. Community participation has, and will continue, to shape the design of the study and related dissemination activities. Al individuals with diabetes will be recruited through an IMS Service Unit currently participating in the Special Diabetes Program for Indians and that also includes six dental clinics. These individuals will be screened for severity of periodontal disease and invited to be further considered for participation in the study. After complete periodontal examinations and application of other inclusion and exclusion criteria, participants will be randomly assigned to conditions. The SRP and SRP+ groups will receive treatment at baseline and 3 months, and the TxD group will receive the SRP+ treatment at 6 months. All participants will be examined at baseline, 3 months, and 6 months. Recruitment of participants and treatment will continue until 540 individuals have completed the study protocol. The study participants and examiners will be blinded to treatment condition. Individuals from the participant communities and Al health service providers will be involved in the development of final protocols and procedures, as well as dissemination activities. Differences in responses of participants to treatment will be examined in terms of a set of moderator and mediator variables that will include sociodemographic data, knowledge, attitudes, and behaviors, psychological variables, and comorbidities. Structured as a Phase 3 clinical trial, this study will provide necessary information to make definitive recommendations about the preferred PD treatment for Al patients with diabetes and concurrent PD. These recommendations will take into consideration costs and other factors. Based on HbA1c analyses, the study also may provide critical information for determining next steps in the investigation of the relationship between PD and diabetes control.

RC 2的目标是评估两种治疗牙周病的方法的有效性， 美国印第安人（Als）糖尿病糖尿病和牙周病（PD）是糖尿病的两倍多。 在AI/AN中比在美国普通人群中更常见。与其他糖尿病患者相比， 至少一些AI组也经历PD严重性的差异。最后，先前的研究表明， 这两种情况之间存在系统性联系本研究的具体目标是：1） 比较洁治和根面平整术（SRP）减少糖尿病患者牙周袋深度的效果 洁治和根面平整加局部盐酸米诺环素（SRP+），两者也与 延迟治疗对照条件（TxD）; 2）比较三种治疗条件对额外 3）比较三种方案的糖化血红蛋白（HbA 1c）指标及成本-效果; 以及4）评估治疗的安全性和可接受性。社区参与，以及 将继续为研究和相关传播活动的设计提供指导。所有个人， 将通过目前参与特殊糖尿病计划的IMS服务单位招募糖尿病患者 还包括六家牙科诊所。将对这些个体进行筛查，以确定 牙周病，并邀请进一步考虑参加这项研究。完全后 牙周检查和其他入选和排除标准的应用，参与者将 随机分配到条件。SRP组和SRP+组将在基线和第3天接受治疗。 个月，TxD组将在6个月时接受SRP+治疗。所有参与者都将接受检查 在基线、3个月和6个月时。参与者的招募和治疗将持续到540 个人已完成研究方案。研究参与者和检查员将对以下内容设盲： 处理条件来自参与者社区和Al保健服务提供者的个人将 参与制定最后议定书和程序以及传播活动。 参与者对治疗反应的差异将根据一组调节剂和 中介变量包括社会人口学数据、知识、态度和行为， 心理变量和合并症作为一项3期临床试验，本研究将提供 为Al患者的首选PD治疗提供明确建议的必要信息 糖尿病并发腹膜透析这些建议将考虑到费用和其他因素。 因素基于HbA 1c分析，该研究还可以为确定下一步措施提供关键信息 PD与糖尿病控制关系的研究。