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

NCT ID: NCT06666374

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-11-30

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.

Conditions

Dental Plaque; Periodontal Diseases; Oral Health Behavior Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

OHL Program

This program used OHL as its core structure and incorporated elements of experiential learning and self-efficacy to enhance patient engagement and understanding.

Group Type: EXPERIMENTAL

OHL program

Intervention Type: BEHAVIORAL

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.

Traditional program

Patients acquired traditional oral health instruction from another dental professional, which primarily focused on providing information without the OHL components, self-efficacy strategies, or the interactive elements of the intervention program.

Group Type: ACTIVE_COMPARATOR

Traditional program

Intervention Type: BEHAVIORAL

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

Interventions

OHL 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.

Intervention Type: BEHAVIORAL

Traditional program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

OHL-OHI; Trad-OHI

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Srinakharinwirot University

OTHER

Sponsor Role: lead

Responsible Party

Neeranart Thirasupa

Program director of Residency training program in Orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HRH Princess Maha Chakri Sirindhorn Medical Center

Nakhon Nayok, Changwat Nakhon Nayok, Thailand

Countries

Thailand

Other Identifiers

005/2566

Identifier Type: -

Identifier Source: org_study_id