Public-Use Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth

Abstract

The primary data is accompanied by the raw periodontal data. These are documented in the Data Dictionary and the Manual of Practice files. Citations using the data are included in a text file.The OPT Study was a multi-center randomized, single-blind (examiners) controlled clinical trial testing whether mechanical periodontal therapy (scaling and planing) in pregnant women at risk for premature birth reduced the extent or severity of premature birth. OPT found that periodontal therapy does not reduce the number or timing of premature births. Nonetheless, this public-use dataset is of interest in that it provides natural and clinical histories of the periodontal status of pregnant women with treated and untreated periodontal disease. Data include birth outcomes (including gestational age, birthweight, presence of congenital anomalies, and 1 and 5 minute APGAR scores), baseline characteristics (including previous pregnancy outcomes), periodontal therapy and essential dental care delivered as part of the study, maternal conditions during pregnancy, and the following items for three visits between the end of the first trimester and delivery: clinical periodontal measurements (pocket depth, attachment loss, and bleeding on probing at 6 sites per tooth; site-specific data and several common person-level summaries), medications, dental plaque levels of 8 bacterial species, levels of serum antibodies for the same 8 bacterial species, and serum levels of 8 inflammatory markers or mediators. The OPT Study's Manual of Procedures (Version 1) is available as part of this package. Version changes during the course of the study were rare and affected very few data items (mostly the data describing study periodontal therapy). The public-use dataset includes the version of these data items used in the main and secondary papers. The OPT Study team published the main paper in 2006 in the New England Journal of Medicine and has published 8 secondary papers. The dataset was made available in 2009 but has not previously been available online because the sponsoring agency had no facility for making it available.The data in these files were collected during the OPT Study funded by the National Institute of Dental and Craniofacial Research, grant number DE014338. The ClinicalTrials.gov number is NCT00066131.If you use these archived data from the OPT Study in any publication or presentation, please include the following acknowledgement statement: We thank the OPT Study Group for collecting these data and making them publically available. See N Engl J Med 2006;355:1885-94 for a full listing of the Study Group. The OPT Study was funded by a grant (UO1 DE014338) from the National Institute of Dental and Craniofacial Research