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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000069-44
Application #
7374399
Study Section
Special Emphasis Panel (ZRR1-CR-9 (01))
Project Start
2006-04-24
Project End
2007-02-28
Budget Start
2006-04-24
Budget End
2007-02-28
Support Year
44
Fiscal Year
2006
Total Cost
$35,051
Indirect Cost
Name
University of Colorado Denver
Department
Pediatrics
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
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