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Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi

NCT02333227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10069

Last updated 2024-01-08

Study results available
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Summary

The hypothesis of the investigators' project is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.

Conditions

Interventions

DIETARY_SUPPLEMENT

Xylitol gum

This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Kjersti Aagaard, M.D. · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2021-10-31
Completion
2021-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333227 on ClinicalTrials.gov