This trial is active, not recruiting.

Conditions periodontal diseases, premature birth
Treatment scaling and root planing
Phase phase 3
Sponsor University of Pennsylvania
Start date October 2004
End date May 2008
Trial size 2100 participants
Trial identifier NCT00116974, 801404


This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
scaling and root planing
Scaling and root planing
(Placebo Comparator)
scaling and root planing
Scaling and root planing

Primary Outcomes

Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks
time frame: 9 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Gestational age between 6 and 20 completed weeks Exclusion Criteria: - Periodontal treatment during the pregnancy - Antibiotic use within 2 weeks of enrollment - Use of antimicrobial mouthwash within 2 weeks - Multiple gestation - Known mitral valve prolapse

Additional Information

Official title Periodontal Infection and Prematurity Study
Principal investigator George A Macones, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by University of Pennsylvania.