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

NCT06666374 | Completed DMC

• 1 other identifier: 005/2566
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Periodontal Diseases; Oral Health Behavior Change

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Oral health behavior

  Oral hygiene care, Dietary choice, Dental visit

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

• PI

  Plaque index score

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

Secondary Outcomes (1)

• OHL

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

Study Arms (2)

OHL Program

EXPERIMENTAL

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

Behavioral: OHL program

Traditional program

ACTIVE COMPARATOR

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.

Behavioral: Traditional program

Interventions

OHL program 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.

Also known as: OHL-OHI

OHL Program

Traditional program BEHAVIORAL

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

Also known as: Trad-OHI

Traditional program

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Srinakharinwirot University: lead

Study Sites (1)

HRH Princess Maha Chakri Sirindhorn Medical Center

Nakhon Nayok, Changwat Nakhon Nayok, 26120, Thailand

Location

MeSH Terms

Conditions

Dental Plaque; Periodontal Diseases

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program director of Residency training program in Orthodontics

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: June 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 1.5 years after the publication of results
• Access Criteria: Permitted researchers will be able to access the IPD and supporting information. They will be allowed to receive the Study Protocol and Statistical Analysis Plan (SAP). Researchers must request permission from me first.

Locations

TH (1)