Oral Hygiene Intervention for Adolescents

NCT ID: NCT05158465

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-05-15

Brief Summary

The purpose of this study is to promote oral hygiene behaviors (toothbrushing, flossing) and oral health with high-risk adolescents in San Diego, CA, through a Motivational Interviewing (MI) Intervention.

Detailed Description

This randomized controlled trial (RCT) will evaluate the efficacy of a new, brief motivational interviewing (MI)- based intervention and assess its impact on several sets of outcomes among 14-19 years old Latino adolescents: clinical oral health and hygiene indices, counts of biological caries-causing bacteria, and oral hygiene behaviors. Three one-on-one, half hour educational and skill-building MI sessions will address: proper oral hygiene technique, bacteria and dental caries process, and nutrition. Intervention group adolescents will also receive three telephone calls (one/month reinforcing their hygiene behavior goals. Outcomes will be assessed at baseline (T1), and at one-month (T2), after the intervention group received three MI sessions and three booster calls.

Aim 1. To develop and assess a new Motivational Interviewing (MI)-based behavioral oral health intervention for Latino adolescents in a randomized controlled trial (RCT) design. Finalize all intervention educational materials and scripts and assessment tools.

Aim 2. To assess the efficacy of the brief intervention on reductions in clinically determined outcomes among intervention versus control participants.

Aim 3. To assess the efficacy of the brief intervention on reductions in the presence and count of two types of biological bacteria involved in the dental caries disease process.

Aim 4. To assess the efficacy of the brief intervention in increasing the frequency of daily oral hygiene behaviors, including properly brushing, flossing, and rinsing.

Aim 5. Conduct process evaluation via two focus groups post-intervention to assess the acceptability and feasibility of the intervention and assessments (one for intervention group; one for control group).

The investigators hypothesize that the intervention group will see improved clinical outcomes, lower bacteria counts, and better oral hygiene behavior than the control group.

Conditions

Oral Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Motivational Interviewing and Assessments

Two 1 hour assessments. At each assessment, participant will complete a survey, supply a saliva sample, do a toothpick test, and take a plaque photo. Three one-on-one, half hour educational and skill-building MI sessions will address: proper oral hygiene technique, bacteria and dental caries process, and nutrition. Intervention group adolescents will also receive three calls over one month reinforcing their hygiene behavior goals.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

Intervention will include 3 one-on-one motivational interviewing sessions and 3 follow-up calls with a trained MI health educator. These sessions aim to promote better oral hygiene and oral health.

Assessments Only

Two 1 hour assessments. At each assessment, participant will complete a survey, supply a saliva sample, do a toothpick test, and take a plaque photo.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational Interviewing

Intervention will include 3 one-on-one motivational interviewing sessions and 3 follow-up calls with a trained MI health educator. These sessions aim to promote better oral hygiene and oral health.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• self identifies as Mexican or Mexican-American
• living in Northern San Diego County
• speaks English
• able to access stable internet
• participates in 1 or more program or service at VCC

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vista Community Clinic

UNKNOWN

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Tracy L Finlayson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy L Finlayson, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

Vista Community Clinic

Vista, California, United States

Countries

United States

Other Identifiers

HS-2021-0276

Identifier Type: -

Identifier Source: org_study_id