Caries Transmission Prevention in Alaska Native Infants

NCT ID: NCT00067340

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2006-07-31

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Chlorhexidine mouth rinse

Intervention Type: DRUG

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

Xylitol chewing gum

Intervention Type: OTHER

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

Control

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Chlorhexidine mouth rinse

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• plan to give birth to their infant in a specified city of Alaska

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

David Grossman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Grossman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

U54DE014254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19945-C

Identifier Type: -

Identifier Source: org_study_id