Clinical trial NCT06666374: Effectiveness of an Oral Health Literacy Intervention on Oral Health Behaviors and Plaque Index in Orthodontic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Oral health behavior
timeFrame: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.
measure: PI
timeFrame: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.
Secondary outcomes:
measure: OHL
timeFrame: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.
Other outcomes:
Locations:
city: Nakhon Nayok
country: Thailand
facility: HRH Princess Maha Chakri Sirindhorn Medical Center
Study officials:
References: