INTEGRATED MICROFLUIDIC SYSTEM FOR ORAL DIAGNOSTICS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项研究是为了测试一种通过使用口腔液体来诊断牙周炎（牙龈疾病）的新仪器的能力和准确性。诊断仪器将测试两种类型的液体，牙龈沟液（GCF）和唾液。GCF是积聚在牙齿和牙龈组织之间的液体。液体将通过三种方式收集：1。直接GCF取样：将薄纸薄膜插入牙齿和牙龈之间的空间以吸收液体；2. GCF冲洗取样：患者用生理盐水（含盐量浓度与生物液相似的水）冲洗，并吐入管中；3. 全唾液：病人将唾液吐到一个管子里。共有100名成年患者参与本研究。这些受试者将分为两个患者群体：1)患有活动性牙龈疾病的患病人群；2)低风险人群，无活动性牙龈疾病。所有受试者至少有20颗牙齿，在研究纳入前3个月未因医学或牙科原因接受牙周治疗或抗生素相关治疗。如果患者长期服用已知会影响牙周状况的药物，如抗炎药、阿司匹林和布洛芬，也将被排除在研究之外。患者也将没有代谢性骨疾病的病史，如风湿性关节炎或绝经后骨质疏松症。在大约12个月的研究过程中，患者将被观察6次。如前所述，在每次就诊时，患者将接受口腔液体采集，并对口腔进行彻底检查，包括为研究目的进行测量。患者还将在基线、第6个月和研究访视结束时进行CT/ x线片检查。在口腔液体收集期结束时，受试者将根据患者的需要接受深度清洁（洗牙和牙根刨平）或常规清洁（预防性清洁）。

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. This study is being conducted to test the ability and accuracy of a new instrument in the diagnosis of periodontitis (gum disease) by using fluids from the mouth. The diagnosis instrument will test two types of fluids, gingival crevicular fluid (GCF) and saliva. GCF is the fluid that accumulates between your teeth and gum tissue. The fluids will be collected in three ways: 1. Direct GCF sampling: Thin paper films will be inserted into the space between the teeth and gums to absorb the fluid; 2. GCF rinse sampling: The patient will rinse with saline solution (water with salt content concentration similar to biological fluids) and spit into a tube; 3. Whole saliva: The patient will spit saliva into a tube. A total of 100 adult patients will participate in this study. These subjects will be of two patient populations: 1) diseased population, with active gum disease; and 2) a low-risk disease population, with no active gum disease. All subjects will have at least 20 teeth and not have received periodontal treatment or antibiotic-related therapy for medical or dental reasons 3 months prior to study inclusion. Patients will also be excluded from the study if they receive long-term use of medications known to affect periodontal status such as anti-inflammatory drugs, aspirin, and ibuprofen. The patients will also possess no history of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis. Patients will be seen 6 times over the course of the study over a period of approximately 12 months. At each visit the patient will undergo oral fluid collection, as previously described, and thorough examinations of the mouth, including the taking of measurements for study purposes. Patients will also have CT/radiographs taken at baseline, month 6, and end of study visits. At the end of the oral fluid collection period subjects will receive a deep cleaning (scaling and root planing) or a regular cleaning (prophy), dependent upon patient s needs.