Oral Hygiene Intervention for Adolescents

Project Motivate Me Clinical Trial: Oral Hygiene Intervention for Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Oral Hygiene
• Intervention / Treatment: Behavioral: Motivational Interviewing

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Vista, California, United States, 92084
      • Vista Community Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Plaque Score at 1 month	Plaque levels will be scored for each participant based on photographs taken after the use of a plaque disclosure tablet. This will be scored as low (minimum), moderate, or high (maximum). Lower is better.	At baseline and post-intervention (after about one month)
Change from Baseline in Gum Bleeding at 1 month.	Each participant will use a toothpick to probe 14 points in the mouth (7 points in the maxillary anterior teeth and 7 points in the mandibular anterior teeth). At each point, if the participant bleeds, they are given a score of "1". Then the score is added up at the end of probing each point. Minimum score is 1 and maximum score is 14. Lower score is better and higher score is worse.	at baseline, and post-intervention (after about one month)
Change from Baseline Weekly Toothbrushing at 1 month.	Each participant will self-report frequency of toothbrushing in the past 7 days on a survey. This will be scored as a continuous count (minimum is zero, no set maximum) and whether or not they met ADA recommended guidelines for twice daily brushing. Higher frequency is better.	at baseline, and post-intervention (after about one month)
Change from Baseline in Weekly Flossing at 1 month.	Each participant will self-report frequency of flossing in the last 7 days on a survey. This will be scored as a continuous count (minimum is zero, no set maximum) and whether or not they met ADA recommended guidelines for once daily flossing. Higher frequency is better.	at baseline, and post-intervention (after about one month)
Change from Baseline in Weekly Rinsing at 1 month.	Each participant will self-report frequency of rinsing with water in the last 7 days on a survey. This will be scored as a continuous count (minimum is zero, no set maximum). Higher frequency is better.	at baseline, and post-intervention (after about one month)
Change from Baseline Oral Hygiene at 1 month.	Each participant's oral hygiene skill level will be assessed and scored as poor (minimum), fair, good, or excellent (maximum) based on execution of specific micro-behaviors for brushing and flossing. Higher is better.	at baseline, and post-intervention (after about one month)
Change from Baseline Count in S. Mutans Bacteria in Saliva at 1 month.	Saliva samples will be collected using Zymo collection kits to run qPCR analysis, which will yield information on whether or not bacteria is present (yes/no), and relative and absolute counts of S. mutans bacteria. Minimum is zero, no set maximum. Lower is better.	at baseline, and post-intervention (after about one month)
Change from Baseline Count in S. sobrinus Bacteria in Saliva at 1 month.	Saliva samples will be collected using Zymo collection kits to run qPCR analysis, which will yield information on whether or not bacteria is present (yes/no), and relative and absolute counts of S. sobrinus bacteria. Minimum is zero, no set maximum. Lower is better.	at baseline, and post-intervention (after about one month)

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: Vista Community Clinic
• Investigators: Principal Investigator: Tracy L Finlayson, PhD, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HS-2021-0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No