NCT00066131

Obstetrics and Periodontal Therapy (OPT) Study

Effects of Periodontal Therapy on Preterm Birth

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 823 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).

Detailed description

Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.

Conditions

• Periodontitis
• Infant, Premature

Interventions

Type	Name	Description
PROCEDURE	Periodontal scaling and root planing	Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.
PROCEDURE	Scaling and root planing	Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.

Timeline

• Start date: 2003-03-01
• Primary completion: 2005-12-01
• Completion: 2006-02-01
• First posted: 2003-08-05
• Last updated: 2015-07-27

Locations

1 site across 1 country: United States