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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04286256
Other study ID # 1107M02642
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2011
Est. completion date November 1, 2012

Study information

Verified date February 2020
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study's aim was to investigate if a motivational interviewing intervention (MI) improved oral self-care behaviors of AIAN caregivers of infants and determine if the MI intervention promoted positive changes in caregivers' ECC risk-related behaviors.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 1, 2012
Est. primary completion date November 1, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy mothers/caregivers of infants

Exclusion Criteria:

- Subjects with recent antibiotic use (within 3 months)

- Subjects on any medication that is immunosuppressive

- Subjects who self-report they have xerostomia due to medication use

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
Participants/caregivers will receive several telephone-based and in-person motivational interviewing sessions along with specific oral health recommendations.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Concentration of Lactobacilli Oral concentration of Lactobacilli will be measured using a Caries Risk Test (CRT). Outcome will be reported in colony-forming units per milliliter (CFU/mL). Baseline, 8 months
Primary Change in Concentration of Mutans Streptococcus Oral concentration of Mutans streptococcus will be measured using a Caries Risk Test (CRT). Outcome will be reported in colony-forming units per milliliter (CFU/mL). Baseline, 8 months
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