Periodontal Infection and Prematurity Study
This trial is active, not recruiting.
|Conditions||periodontal diseases, premature birth|
|Treatment||scaling and root planing|
|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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
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
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
|Official title||Periodontal Infection and Prematurity Study|
|Principal investigator||George A Macones, M.D.|
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