Periodontal Infection and Prematurity Study

University of Pennsylvania

Status and phase: Terminated; Phase 3

Conditions: Periodontal Diseases; Premature Birth

Treatments: Procedure: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT00116974

801404

Details and patient eligibility

About

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.

Enrollment: 2,100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,100 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Procedure: Scaling and root planing

2

Placebo Comparator group

Treatment:

Procedure: Scaling and root planing