COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Obstetrics and Periodontal Therapy (OPT) Study (OPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066131
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : July 27, 2015
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE August 4, 2003
First Posted Date  ICMJE August 5, 2003
Last Update Posted Date July 27, 2015
Study Start Date  ICMJE March 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Gestational age at birth [ Time Frame: At delivery ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Infant birth weight [ Time Frame: At delivery ]
  • Periodontal probing depth [ Time Frame: 29-32 weeks of gestation ]
  • Clinical attachment loss [ Time Frame: 29-32 weeks of gestation ]
  • Bleeding following periodontal probing [ Time Frame: 29-32 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Obstetrics and Periodontal Therapy (OPT) Study
Official Title  ICMJE Effects of Periodontal Therapy on Preterm Birth
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Periodontitis
  • Infant, Premature
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Scaling and root planing
    Scaling and root planing delivered prior to 21 weeks of gestation.
    • 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.
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2011)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • 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


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00066131
Other Study ID Numbers  ICMJE 0104M94001
NIDCR-DE014338 ( Other Identifier: NIDCR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
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
PRS Account University of Minnesota
Verification Date July 2015

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