Oral Hygiene Intervention for Adolescents

NCT05158465 | Completed

• 1 other identifier: HS-2021-0276
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Motivational Interviewing and Assessments

EXPERIMENTAL

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

Assessments Only

NO INTERVENTION

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.

Interventions

Motivational Interviewing 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.

Motivational Interviewing and Assessments

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• Vista Community Clinic: collaborator

Study Sites (1)

Vista Community Clinic

Vista, California, 92084, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tracy L Finlayson, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention and control groups will be enrolled and followed over one-month.

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: December 15, 2021
• Study Start: May 1, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)