Dental PlaqueNCT06666374
Effectiveness of an Oral Health Literacy Intervention on Oral Health Behaviors and Plaque Index in Orthodontic Patients
A study testing OHL program and Traditional program in people with Dental Plaque and Periodontal Diseases, run by Srinakharinwirot University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Periodontal Diseases, Oral Health Behavior Change
- What is being tested?
- OHL program and Traditional program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- reluctance to provide health information, inability to complete assessments, or withdrawal from the program at any stage.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
HRH Princess Maha Chakri Sirindhorn Medical Center
Nakhon Nayok, Changwat Nakhon Nayok, 26120
About this study
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
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.
Read the 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.
- Being tested
- OHL program, Traditional program
- Keywords
- Oral health literacy, Self-efficacy, Experiential learning, Oral health intervention, Oral health behavior, Plaque index
- Medical subject headings
- Dental Plaque, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHL programBehavioural
Also called OHL-OHI
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 programBehavioural
Also called Trad-OHI
Program primarily focused on providing information without the OHL components, self-efficacy strategies, or the interactive elements of the intervention program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health behavior
Oral hygiene care, Dietary choice, Dental visit
Measured: 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
Measured: 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
Oral health literacy
Measured: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Jun 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinakharinwirot University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neeranart Thirasupa, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666374
- Sponsor's protocol ID
- 005/2566
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06666374
- Acronym / sponsor ID
- 005/2566
- Keywords
- Oral health literacy, Self-efficacy, Experiential learning, Oral health intervention, Oral health behavior, Plaque index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Srinakharinwirot UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OHL Program | Experimental | Behavioral: OHL programThis program used OHL as its core structure and incorporated elements of experiential learning and self-efficacy to enhance patient engagement and understanding. |
| Traditional program | Active comparator | Behavioral: Traditional programPatients 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. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- reluctance to provide health information, inability to complete assessments, or withdrawal from the program at any stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OHL programAlso: OHL-OHIThis 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. | Behavioural | OHL Program |
| Traditional programAlso: Trad-OHIProgram primarily focused on providing information without the OHL components, self-efficacy strategies, or the interactive elements of the intervention program. | Behavioural | Traditional program |
Primary outcome
Oral health behavior
Time frame: 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
Time frame: 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
1 secondary outcome
OHL
Time frame: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHL program and Traditional program in people with Dental Plaque and Periodontal Diseases, run by Srinakharinwirot University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health behavior (time frame: Outcomes were measured at baseline, post-intervention, and at a 3-week follow-up, with a total study duration averaging 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.