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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

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
Periodontitis Infant, Premature 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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : February 2006

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 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.

No Intervention: Placebo
Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery.

Primary Outcome Measures :
  1. Gestational age at birth [ Time Frame: At delivery ]

Secondary Outcome Measures :
  1. Infant birth weight [ Time Frame: At delivery ]
  2. Periodontal probing depth [ Time Frame: 29-32 weeks of gestation ]
  3. Clinical attachment loss [ Time Frame: 29-32 weeks of gestation ]
  4. Bleeding following periodontal probing [ Time Frame: 29-32 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066131

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United States, Minnesota
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)
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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
Publications of Results:
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Responsible Party: University of Minnesota Identifier: NCT00066131    
Other Study ID Numbers: 0104M94001
NIDCR-DE014338 ( Other Identifier: NIDCR )
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases