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Caries Transmission Prevention in Alaska Native Infants

Primary Purpose

Dental Caries

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine mouth rinse
Xylitol chewing gum
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 15, 2003
Last Updated
May 29, 2015
Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00067340
Brief Title
Caries Transmission Prevention in Alaska Native Infants
Official Title
Northwest Alaska Center to Reduce Oral Health Disparity Project 2: Caries Transmission Prevention in Alaska Native Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit sufficient number of subjects
Study Start Date
April 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Alaska Native children are disproportionately affected by early childhood caries, compared to all U.S children. Dental care needs for adults and children in rural Alaska far exceed the acute care and prevention resources available. As a result, there is a high level of dental morbidity present among adults that likely contributes to early transmission of mutans streptococci (MS) from adult caregivers to infants in the household. Furthermore, the cultural practice of pre-mastication of solid food for infant feeding amplifies the transmission of oral secretions from adult to child. The prevention of early MS acquisition and subsequent caries in infants and toddlers requires efforts starting at birth. Since Alaska Natives are a rural population at high risk for caries, interruption of vertical transmission of MS using a combination of improved oral hygiene practices, and topical antimicrobials and bacteriostatic agents may be an ideal prevention strategy for childhood caries. Chlorhexidine and xylitol are two agents that have been shown to reduce dental decay and MS counts. The specific aim of this proposal is to conduct a community based, randomized blinded trial to determine if the serial use of chlorhexidine and xylitol will reduce the vertical transmission of caries between Alaska Native mothers and infants. We hypothesize that a two week period of twice-daily chlorhexidine mouthwash use prior to delivery, followed by a subsequent two year period of maternal xylitol gum use, will lead to a significant reduction in the age-specific prevalence of early childhood caries at 12 and 24 months of age among the offspring of mothers in the intervention group, compared to control group mothers. We also hypothesize that, compared to controls, mothers and children in the intervention group will have significant reductions in oral MS counts at each follow-up interval. If proven successful, this intervention could have a significant impact on the prevalence of caries among young Alaska Native children and other population groups at high risk for childhood caries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects received chlorhexidine mouthwash and xylitol gum , in addition to the usual care specified under the control group
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects received enhanced dental care, health information, toothbrushes and toothpaste. They also received placebo gum and placebo mouth rinse
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouth rinse
Intervention Description
women received daily chlorhexidine oral rinses for two weeks prior to delivery of the infant.
Intervention Type
Other
Intervention Name(s)
Xylitol chewing gum
Intervention Description
Women were asked to chew xylitol chewing gum three times per day following the birth of their infant for up to two years postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Grossman, MD MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Caries Transmission Prevention in Alaska Native Infants

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