Obstetrics and Periodontal Therapy (OPT) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

823 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-02-28

Brief Summary

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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).

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Detailed Description

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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

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Periodontitis Infant, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Scaling and root planing

Scaling and root planing delivered prior to 21 weeks of gestation.

Group Type ACTIVE_COMPARATOR

Periodontal scaling and root planing

Intervention Type PROCEDURE

Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.

Scaling and root planing

Intervention Type PROCEDURE

Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.

Placebo

Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Deep cleaning

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No