Obstetrics and Periodontal Therapy (OPT) Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00066131
First received: August 4, 2003
Last updated: August 16, 2011
Last verified: August 2011

August 4, 2003
August 16, 2011
March 2003
December 2005   (final data collection date for primary outcome measure)
Gestational age at birth [ Time Frame: At delivery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00066131 on ClinicalTrials.gov Archive Site
  • Infant birth weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Periodontal probing depth [ Time Frame: 29-32 weeks of gestation ] [ Designated as safety issue: No ]
  • Clinical attachment loss [ Time Frame: 29-32 weeks of gestation ] [ Designated as safety issue: No ]
  • Bleeding following periodontal probing [ Time Frame: 29-32 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Obstetrics and Periodontal Therapy (OPT) Study
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Periodontitis
  • Infant, Premature
  • 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 Name: 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.
  • Active Comparator: Scaling and root planing
    Scaling and root planing delivered prior to 21 weeks of gestation.
    Interventions:
    • Procedure: Periodontal scaling and root planing
    • Procedure: Scaling and root planing
  • No Intervention: Placebo
    Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
823
February 2006
December 2005   (final data collection date for primary outcome measure)

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
Female
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066131
0104M94001, NIDCR-DE014338
Yes
Bryan S. Michalowicz, University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
National Institute of Dental and Craniofacial Research (NIDCR)
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
University of Minnesota - Clinical and Translational Science Institute
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP