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Effectiveness of an Oral Health Literacy Intervention on Oral Health Behaviors and Plaque Index in Orthodontic Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06666374
Enrollment
78
Registered
2024-10-30
Start date
2023-06-01
Completion date
2023-11-30
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque, Oral Health Behavior Change, Periodontal Diseases

Keywords

Oral health literacy, Self-efficacy, Experiential learning, Oral health intervention, Oral health behavior, Plaque index

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALOHL program

This program used OHL as its core structure and incorporated elements of experiential learning and self-efficacy to enhance patient engagement and understanding. The program comprised seven steps designed to guide patients through key aspects of oral health care, enabling them to progressively build their skills and confidence. These steps included personalized education on oral health, hands-on practice of proper oral hygiene techniques, self-assessment exercises, and strategies for overcoming barriers to good oral health.

Program primarily focused on providing information without the OHL components, self-efficacy strategies, or the interactive elements of the intervention program.

Sponsors

Srinakharinwirot University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Oral health behaviorOutcomes 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
PIOutcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.Plaque index score

Secondary

MeasureTime frameDescription
OHLOutcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.Oral health literacy

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026