Obstetrics and Periodontal Therapy (OPT) Study (OPT)

Effects of Periodontal Therapy on Preterm Birth

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).

Study Overview

• Status: Completed
• Conditions: Periodontitis; Infant, Premature
• Intervention / Treatment: Procedure: Periodontal scaling and root planing; Procedure: Scaling and root planing

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 Type: Interventional
• Enrollment (Actual): 823
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Univerisity of Minnesota School Of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion

• Be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound
• Be at least 16 years of age
• Have at least 20 natural teeth,
• Have bleeding on probing (BOP) on at least 35% of all tooth sites
• Have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm

Exclusion

• Are unable to provide informed consent or are unable to cooperate with the study protocol.
• May be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy).
• Have multiple fetuses as diagnosed by ultrasound.
• Require antibiotic prophylaxis for periodontal procedures
• Require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scaling and root planing; Scaling and root planing delivered prior to 21 weeks of gestation.	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.; Other Names: Deep cleaning; 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.
No Intervention: Placebo; Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gestational age at birth	At delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Study Director: Panos Papapanou, DDS, PhD, Harlem Hospital; Study Director: Anthony DiAngelis, DMD, Hennepin County Medical Center, Minneapolis; Study Director: William Buchanan, DDS, Jackson Medical Mall; Study Director: John Novak, DDS, University of Kentucky

Publications and helpful links

General Publications

• Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2;355(18):1885-94. doi: 10.1056/NEJMoa062249.

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: August 4, 2003
• First Submitted That Met QC Criteria: August 4, 2003
• First Posted (Estimate): August 5, 2003

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 0104M94001; NIDCR-DE014338 (Other Identifier: NIDCR)