Project Motivate Me Clinical Trial: Oral Hygiene Intervention for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change from Baseline in Plaque Score at 1 month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to condition.
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Change from Baseline in Plaque Score at 1 month
时间窗: At baseline and post-intervention (after about one 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.
Change from Baseline in Gum Bleeding at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
Change from Baseline Weekly Toothbrushing at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
Change from Baseline in Weekly Flossing at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
Change from Baseline in Weekly Rinsing at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
Change from Baseline Oral Hygiene at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
Change from Baseline Count in S. Mutans Bacteria in Saliva at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
Change from Baseline Count in S. sobrinus Bacteria in Saliva at 1 month.
时间窗: at baseline, and post-intervention (after about one 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.
次要结局
未报告次要终点
研究者
Tracy L Finlayson
Principal Investigator
San Diego State University