Obstetrics and Periodontal Therapy (OPT) Study

Periodontitis Clinical Trial

— OPT  

Official title:

Effects of Periodontal Therapy on Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066131
• Other study ID #: 0104M94001
• Secondary ID: NIDCR-DE014338
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2003
• Last updated: July 24, 2015
• Start date: March 2003
• Est. completion date: February 2006

Study information

• Verified date: July 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: February 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant, Premature
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Univerisity of Minnesota School Of Dentistry	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at birth		At delivery	No
Secondary	Infant birth weight		At delivery	No
Secondary	Periodontal probing depth		29-32 weeks of gestation	No
Secondary	Clinical attachment loss		29-32 weeks of gestation	No
Secondary	Bleeding following periodontal probing		29-32 weeks	No