Methods: The OPT Study is an ongoing, phase-III, randomized trial with planned enrollment of 816 pregnant women at four diverse sites. Women are enrolled at 13-16 weeks of gestation and randomly assigned to receive periodontal treatment either before 20 weeks of gestation (test) or after delivery (control). Test subjects are seen for monthly tooth polishing and oral hygiene instruction, while control subjects are seen at the same intervals for placebo visits. Gestational age at the end of pregnancy is the primary outcome.
Results: Through September 2004, over 2,200 women have been screened and 575 randomized. About 44% are Hispanic and 43% are black. Over two-thirds are receiving public assistance. Among women who have previously been pregnant, 13% have a history of preterm delivery. At baseline, subjects have an average of about 15 teeth with probing depths >= 4 mm and attachment loss >= 2mm; 68% of tooth sites bleed on probing. Over 87% of subjects have missed zero or one follow-up visit at three of the enrollment sites, and fewer than 3% of subjects overall have been lost to follow-up. Across the sites, 40-73% of women require “essential” restorative or endodontic care, which is offered to all women before 20 weeks.
Conclusion: The OPT Study is a cross-disciplinary clinical trial in which investigative teams have established relationships between clinical dental researchers and obstetrical care providers. Despite the presumed difficulties of studying economically disadvantaged women at risk for adverse pregnancy outcomes, the OPT study has succeeded in recruiting and retaining women at primary care sites.
Supported by NIH/NIDCR grant DE14338.