CLINICAL TRIAL: EFFICACY AND SAFETY OF A NOVEL PROTOTYPE POWER TOOTHBRUSH EVALUA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是评估新型电动牙刷原型的有效性和安全性，该牙刷融合了声波和超声波物理过程的组合，用于中度牙周炎人群。声波/超声波牙刷的原型将与手动牙刷进行比较(Oral B？P35)。这项研究将包括大约83名参与者，随机分配到两个治疗组，检查人员对治疗视而不见。这项研究将包括对每个参与者的5次研究访问，在访问中将评估以下所有临床参数： ？斑块与斑块密度与L斑块与斑块指数 ？L与宁静牙合指数 ？全口牙周探诊深度 ？临床依恋水平(CAL) ？探查出血(BOP) ？龈沟液中细胞因子水平的研究 ？牙周上、下菌斑的微生物分析 ？病例报告表上记录的不良事件

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to evaluate the efficacy and safety of the novel prototype power toothbrush incorporating a combination of sonic and ultrasonic physical processes in a population with moderate gingivitis. Comparison of the prototype sonic/ultrasonic toothbrush will be made to a manual toothbrush (Oral B?P35). This study will include approximately 83 participants randomized to two treatment arms with the examiner blinded to the treatment. The study will include 5 study visits for each participant in which all of the following clinical parameters will be evaluated: ? Plaque and Stain Silness and L¿e Plaque and Stain Index ? L¿e and Silness Gingival Index ? Full mouth periodontal probing depths ? Clinical attachment levels (CAL) ? Bleeding on Probing (BOP) ? Level of cytokines in the gingival crevicular fluid ? Microbial analysis of supragingival and subgingival plaque ? Adverse Events recorded on Case Report Forms