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A Pilot Study to Promote Maternal and Infant Oral Health

NCT ID: NCT00719238

Last Updated: 2008-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-07-31

Brief Summary

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The long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Nutrition plus education

Intervention Type BEHAVIORAL

Nutritional instruction in small groups plus education

2

Group Type ACTIVE_COMPARATOR

Education only

Intervention Type BEHAVIORAL

Educational video and pamphlets

Interventions

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Nutrition plus education

Nutritional instruction in small groups plus education

Intervention Type BEHAVIORAL

Education only

Educational video and pamphlets

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 or over;
* Pregnant
* High S. mutans levels

Exclusion Criteria

* Younger than 18;
* Other health conditions
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Connecticut Health Foundation

OTHER

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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University of Connecticut School of Dental Medicine

Principal Investigators

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Susan Reisine, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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CTF2007

Identifier Type: -

Identifier Source: secondary_id

07-093-02

Identifier Type: -

Identifier Source: org_study_id