NCT00067340

Brief Summary

The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 2, 2015

Status Verified

April 1, 2010

Enrollment Period

3.3 years

First QC Date

August 15, 2003

Last Update Submit

May 29, 2015

Conditions

Dental Caries

Study Arms (2)

Intervention group

EXPERIMENTAL

Subjects received chlorhexidine mouthwash and xylitol gum , in addition to the usual care specified under the control group

Drug: Chlorhexidine mouth rinseOther: Xylitol chewing gum

Control

PLACEBO COMPARATOR

Subjects received enhanced dental care, health information, toothbrushes and toothpaste. They also received placebo gum and placebo mouth rinse

Interventions

Chlorhexidine mouth rinseDRUG

women received daily chlorhexidine oral rinses for two weeks prior to delivery of the infant.

Intervention group
Xylitol chewing gumOTHER

Women were asked to chew xylitol chewing gum three times per day following the birth of their infant for up to two years postpartum

Intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* primiparous or multiparous pregnant Alaska Native mothers of all ages * in the last month of pregnancy * reside in the health service delivery area of the native health corporation, in one of the communities with the highest birth counts from 2002 * eligible for obstetric care from the health corporation * plan to give birth to their infant in a specified city of Alaska

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • David Grossman, MD MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2003

First Posted

August 20, 2003

Study Start

April 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

June 2, 2015

Record last verified: 2010-04

Locations

US(1)