Periodontal Infection and Prematurity Study

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116974

Enrollment

2100

Registered

2005-07-01

Start date

2004-10-31

Completion date

2009-02-28

Last updated

2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Premature Birth

Keywords

Dental scaling

Brief summary

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.

Interventions

PROCEDUREScaling and root planing

Scaling and root planing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026