FORMOCRESOL BLOOD LEVELS IN CHILDREN RECEIVING DENTAL TREATMENT

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。福摩甲酚是一种常用的药物，用于治疗需要治疗性的重要牙髓切开术的乳牙。关键髓切开术指的是在乳牙中进行部分根管治疗，其中通过手术切除神经的冠状部分，并用福摩甲酚等药物固定牙髓组织的最冠状残端。重要的牙髓切开术也常被称为乳牙的“牙髓治疗”。尽管已知高全身浓度的甲醛甲酚具有致突变性、致癌性和毒性，但没有关于人类截髓治疗后全身摄取（血浆浓度）的数据。因此，本研究的目的是确定全麻下接受牙髓综合口腔康复治疗的儿童是否存在福摩甲酚的血药浓度（如果存在的话）及其时间基础。我们的目标是招募大约40名受试者参加这项研究，以获得30组最终/可用的数据。本研究将受试者分为两组：低剂量福尔摩甲酚组（3颗及以下牙齿接受截髓术）和高剂量福尔摩甲酚组（4颗及以上牙齿接受截髓术）。虽然这些剂量是人为的和手术确定的剂量，但应该注意的是，定期对儿童的乳牙进行4次或更多的福尔摩甲酚牙髓切开术是标准操作程序。在所有全身麻醉过程中，将从静脉导管中抽取血清标本，分析甲醛甲酚的浓度。本研究的结果数据将有助于为在牙科中使用福摩甲酚建立适当的指导方针，并使与以往动物研究的相关性更加相关。

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. Formocresol is a medicament commonly used in the treatment of primary teeth requiring therapeutic, vital pulpotomy. A vital pulpotomy refers to partial root canal therapy in primary teeth wherein the coronal portion of the nerve is surgically removed and the most coronal stump of pulp tissue is fixed with a medicament such as formocresol. A vital pulpotomy is also often referred to as "pulp therapy" in primary teeth. Despite the fact that in high systemic concentrations formocresol has known mutagenic, carcinogenic, and toxic potential, no data exists regarding systemic uptake (plasma concentration) after pulpotomy treatment in humans. Thus, the purpose of this study is to determine the existence, if any, and time-based plasma concentration of formocresol in children undergoing comprehensive oral rehabilitation involving pulp therapy under general anesthesia. We aim to enroll approximately 40 subjects into this study to attain 30 final/useable sets of data. Subjects for this study will be divided into two groups: low dose formocresol (3 or less teeth receiving pulpotomy) and high dose formocresol (4 or more teeth receiving pulpotomy). Although these are artificial and operationally defined doses, it should be noted that it is standard operating procedure to do 4 or more formocresol pulpotomies on primary teeth in children on a regular basis. Serum specimens will be drawn from an intravenous catheter placed during all general anesthesia procedures and analyzed for concentration of formocresol. The resulting data from this study will help to establish appropriate guidelines for the use of formocresol in dentistry and to make correlation with previous animal studies more relevant.