FORMOCRESOL BLOOD LEVELS IN CHILDREN RECEIVING DENTAL TREATMENT

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。甲醛甲酚是一种常用于治疗需要治疗性活髓切断术的乳牙的药物。活髓切断术是指乳牙的部分根管治疗，其中神经的冠状部分被手术切除，并且牙髓组织的最冠状残端用药物如甲醛甲酚固定。活髓切断术通常也被称为乳牙的“牙髓治疗”。尽管高全身浓度的甲甲酚具有已知的致突变性、致癌性和毒性潜力，但没有关于人类活髓切断术治疗后全身摄取（血浆浓度）的数据。因此，本研究的目的是确定是否存在，如果有的话，和基于时间的血浆浓度的福尔甲酚在儿童进行全面的口腔康复，包括牙髓治疗全身麻醉。我们的目标是入组约40例受试者，以获得30组最终/可用数据。本研究的受试者将分为两组：低剂量甲醛甲酚（3颗或更少牙齿接受活髓切断术）和高剂量甲醛甲酚（4颗或更多牙齿接受活髓切断术）。虽然这些是人工和操作定义的剂量，但应该注意的是，定期对儿童乳牙进行4次或更多次甲醛甲酚活髓切断术是标准操作程序。将从所有全身麻醉手术期间放置的静脉导管中采集血清样本，并分析甲甲酚浓度。本研究的结果将有助于建立适当的指导方针，在牙科中使用甲醛甲酚，并使相关性与以前的动物研究更相关。

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.