Obstetrics and Periodontal Therapy (OPT) Study

Study Overview
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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).

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.

Official Title
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Effects of Periodontal Therapy on Preterm Birth

Conditions
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Periodontitis, Infant, Premature

Intervention / Treatment
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* Procedure: Periodontal scaling and root planing
* Procedure: Scaling and root planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scaling and root planing<br>Scaling and root planing delivered prior to 21 weeks of gestation. | Procedure: Periodontal scaling and root planing<br>* Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.<br>* Other names: Deep cleaning;Procedure: Scaling and root planing<br>* Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.<br>|
| No Intervention: Placebo<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at birth |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |