Clinical trial NCT05158465: Oral Hygiene Intervention for Adolescents
Official title: Project Motivate Me Clinical Trial: Oral Hygiene Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Vista Community Clinic
First posted: 2021-12-15
Enrollment: 8
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control groups will be enrolled and followed over one-month.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from Baseline in Plaque Score at 1 month
timeFrame: At baseline and post-intervention (after about one month)
measure: Change from Baseline in Gum Bleeding at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
measure: Change from Baseline Weekly Toothbrushing at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
measure: Change from Baseline in Weekly Flossing at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
measure: Change from Baseline in Weekly Rinsing at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
measure: Change from Baseline Oral Hygiene at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
measure: Change from Baseline Count in S. Mutans Bacteria in Saliva at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
measure: Change from Baseline Count in S. sobrinus Bacteria in Saliva at 1 month.
timeFrame: at baseline, and post-intervention (after about one month)
Secondary outcomes:
Other outcomes:
Locations:
city: Vista
country: United States
facility: Vista Community Clinic
state: California
Study officials:
affiliation: San Diego State University
name: Tracy L Finlayson, PhD
role: PRINCIPAL_INVESTIGATOR
References: