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Completed

NCT Number: NCT00066131

Obstetrics and Periodontal Therapy (OPT) Study

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).

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Key information

Conditions

Periodontitis Female Urogenital Diseases and Pregnancy Complications Infant, Premature Mouth Diseases Obstetric Labor Complications Obstetric Labor, Premature Periodontal Diseases Pregnancy Complications Premature Birth Stomatognathic Diseases Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Univerisity of Minnesota School Of Dentistry

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal Scaling and Root Planing

Procedure

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

Scaling and Root Planing

Procedure

Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.

Primary outcomes

  1. Gestational age at birth

    Time frame: At delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Effects of Periodontal Therapy on Preterm Birth

Acronym: OPT

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Aug 5, 2003
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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