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Caries Transmission Prevention in Alaska Native Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00067340
Recruitment Status : Terminated (Unable to recruit sufficient number of subjects)
First Posted : August 20, 2003
Last Update Posted : June 2, 2015
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
David Grossman, University of Washington

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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Chlorhexidine mouth rinse Other: Xylitol chewing gum Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Northwest Alaska Center to Reduce Oral Health Disparity Project 2: Caries Transmission Prevention in Alaska Native Infants
Study Start Date : April 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Arm Intervention/treatment
Experimental: Intervention group
Subjects received chlorhexidine mouthwash and xylitol gum , in addition to the usual care specified under the control group
Drug: Chlorhexidine mouth rinse
women received daily chlorhexidine oral rinses for two weeks prior to delivery of the infant.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00067340

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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: David Grossman, MD MPH University of Washington
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Responsible Party: David Grossman, Professor, University of Washington Identifier: NCT00067340    
Other Study ID Numbers: 19945-C
U54DE014254 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: April 2010
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents