Obstetrics and Periodontal Therapy (OPT) Study

Phase 3

Completed

• Conditions: Periodontitis; Infant, Premature
• Interventions: Procedure: Periodontal scaling and root planing; Procedure: Scaling and root planing

• Registration Number: NCT00066131
• Lead Sponsor: University of Minnesota

Brief 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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-08-04
• Study First Submitted QC: 2003-08-04
• Study First Posted: 2003-08-05
• Primary Completion: 2005-12
• Study Completion: 2006-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 823

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and root planing	Scaling and root planing	Scaling and root planing delivered prior to 21 weeks of gestation.
Scaling and root planing	Periodontal scaling and root planing	Scaling and root planing delivered prior to 21 weeks of gestation.

Primary Outcome Measures

Name	Time	Method
Gestational age at birth	At delivery

Secondary Outcome Measures

Name	Time	Method
Infant birth weight	At delivery
Clinical attachment loss	29-32 weeks of gestation
Bleeding following periodontal probing	29-32 weeks
Periodontal probing depth	29-32 weeks of gestation

Trial Locations

Locations (1)

Univerisity of Minnesota School Of Dentistry; 🇺🇸 Minneapolis, Minnesota, United States