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Obstetrics and Periodontal Therapy (OPT) Study

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT00066131
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
823
Enrollment
1
Location
2
Arms
35.1
Duration (Months)
23.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Periodontal scaling and root planing
  • Procedure: Scaling and root planing
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
823 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of Periodontal Therapy on Preterm Birth
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Feb 1, 2006

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Gestational age at birth [At delivery]

    Secondary Outcome Measures

    1. Infant birth weight [At delivery]

    2. Periodontal probing depth [29-32 weeks of gestation]

    3. Clinical attachment loss [29-32 weeks of gestation]

    4. Bleeding following periodontal probing [29-32 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univerisity of Minnesota School Of Dentistry Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00066131
    Other Study ID Numbers:
    • 0104M94001
    • NIDCR-DE014338
    First Posted:
    Aug 5, 2003
    Last Update Posted:
    Jul 27, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Periodontitis

    Study Results

    No Results Posted as of Jul 27, 2015