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
  Purpose

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 Intervention Phase
Periodontitis
Infant, Premature
Procedure: Periodontal scaling and root planing
Procedure: Scaling and root planing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Periodontal Therapy on Preterm Birth

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Gestational age at birth [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 823
Study Start Date: March 2003
Study Completion Date: February 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066131

Locations
United States, Minnesota
Univerisity of Minnesota School Of Dentistry
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
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
  More Information

Publications:
Responsible Party: Bryan S. Michalowicz, University of Minnesota
ClinicalTrials.gov Identifier: NCT00066131     History of Changes
Other Study ID Numbers: 0104M94001, NIDCR-DE014338
Study First Received: August 4, 2003
Last Updated: August 16, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 22, 2014