跳至主要内容
临床试验/NCT06666374
NCT06666374已完成不适用

Evaluating the Effectiveness and Persistence of an Oral Health Literacy Intervention on Oral Health Behaviors and Plaque Reduction in Orthodontic Patients: a Randomized Controlled Trial

Srinakharinwirot University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Oral health behavior

研究概览

简要总结

This study aims to evaluate the effectiveness of a novel psychologic-based oral health instruction program (OHL program) by comparing oral health behaviors (OHB) and plaque index (PI) scores between intervention and control groups at three key time points-pre-intervention, post-intervention, and follow-up-enabling a comprehensive assessment of the intervention's impact and and persistence over time. The study hypothesizes that (1) the OHL program will lead to greater improvements in OHL compared to a traditional control group and (2) these effects will be sustained through the follow-up period.

Participants in the intervention group received the OHL program, while those in the control group received traditional oral hygiene instruction. Both groups had data collected at baseline, post-intervention, and at a 3-week follow-up.

详细描述

The outcomes were oral health behavior (OHB) and plaque index (PI), compared at three time points: baseline (initial), post-intervention (final), and at a 3-week follow-up. Additionally, as a manipulation check, oral health literacy (OHL) levels were assessed at all three intervals.

Demographic information, OHL, and OHB were measured using standardized questionnaires from previous research. The 31-item OHL scale assessed five elements: 1) access, 2) understanding, 3) evaluation, 4) application, and 5) communication of oral health information and services. A 14-item scale evaluated OHB across three domains: 1) oral hygiene practices, 2) dietary choices, and 3) utilization of dental services.

In addition, clinical assessments of plaque were conducted using the Silness and Löe plaque index (PI, 1964). Plaque was evaluated on four surfaces of each tooth (mesial, distal, buccal, and lingual) using a WHO probe. Scores ranged from 0 to 3, reflecting the absence to a large amount of plaque accumulation, based on their established criteria. A single oral examiner recorded the plaque scores for each surface, and the average score for each tooth was calculated. The total score was then summed and divided by the total number of teeth examined, providing an overall plaque index for each individual. There were no outcome changes after trial commencement.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • participants undergoing fixed orthodontic treatment, free from non-communicable chronic diseases (such as diabetes mellitus, hypertension, and heart disease), capable of reading, writing, and providing informed consent, and willing to participate in the oral health program.

排除标准

  • reluctance to provide health information, inability to complete assessments, or withdrawal from the program at any stage.

结局指标

主要结局

Oral health behavior

时间窗: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.

Oral hygiene care, Dietary choice, Dental visit

PI

时间窗: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.

Plaque index score

次要结局

  • OHL(Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neeranart Thirasupa

Program director of Residency training program in Orthodontics

Srinakharinwirot University

研究点 (2)

Loading locations...

相似试验