Clinical trial NCT00066131: Obstetrics and Periodontal Therapy (OPT) Study
Official title: Effects of Periodontal Therapy on Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Infant, Premature
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2003-08-05
Enrollment: 823
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Gestational age at birth
timeFrame: At delivery
Secondary outcomes:
measure: Infant birth weight
timeFrame: At delivery
measure: Periodontal probing depth
timeFrame: 29-32 weeks of gestation
measure: Clinical attachment loss
timeFrame: 29-32 weeks of gestation
measure: Bleeding following periodontal probing
timeFrame: 29-32 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univerisity of Minnesota School Of Dentistry
state: Minnesota
Study officials:
affiliation: Harlem Hospital
name: Panos Papapanou, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Hennepin County Medical Center, Minneapolis
name: Anthony DiAngelis, DMD
role: STUDY_DIRECTOR
affiliation: Jackson Medical Mall
name: William Buchanan, DDS
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: John Novak, DDS
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1056/NEJMoa062249.