Oral HygieneNCT07585448
Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals
A study testing ATP and ATP with song in people with Oral Hygiene and Visually Impaired Persons, run by Mahidol University at 2 sites in Nepal.
Trial summary
The goal of this match-pair randomized study is to compare the effectiveness of the standard Audio-Tactile Performance (ATP) technique with a song-based adaptation (ATP/S) in teaching oral hygiene in visually impaired individuals aged 6 to 20 years in Kathmandu, Nepal. 1. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Oral Hygiene, Visually Impaired Persons
- What is being tested?
- ATP and ATP with song
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNepal
- Study dates
- 9 Jun 2025to 30 Oct 2025
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Bilateral visually impaired in age 6-20yrs. (as verified in school medical record)
Who cannot join
- Visual impairment associated with any disabilities that affected arm motor skill/loss of upper dexterous extremity/abnormal mental development/deaf.
- Using any chemical plaque control agent.
- Individuals with calculus on examining teeth
- On medications that could affect the gingival status.
- Inability to brush due to pain from severe caries/oro-mucosal conditions.
- Have less than 4 teeth in each quadrant.
Show all 9Show fewer
- Presented with orthodontic or prosthodontic appliance.
- Subject with good oral hygiene ; plaque score = 0
- Un co-operative children.
Trial locations and contacts
2 sites in 1 country.
Nepal2 sites
Laboratory boarding Secondary school
Ki̇̄rtipur, Kathmandu, 44600
Namuna Macchindra secondary school
Lalitpur, Lagankhel, 44600
About this study
Official title: Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals: A Matched-Pair Randomized Study
The goal of this match-pair randomized study is to compare the effectiveness of the standard Audio-Tactile Performance (ATP) technique with a song-based adaptation (ATP/S) in teaching oral hygiene in visually impaired individuals aged 6 to 20 years in Kathmandu, Nepal.
- Can the ATP/S approach achieve a greater improvement in plaque control, as measured by the Patient Hygiene Performance (PHP) index, compared to standard ATP instruction over a two-week period?
- Does the rhythmic structure of a song lead to a more continuous improvement in toothbrushing task performance and theoretical oral health knowledge?
Researchers will compare a control group receiving standard ATP with an audio information file to an intervention group receiving ATP with a sing-along song to see if rhythmic auditory stimuli help regulate sequencing and reduce working-memory demands during complex motor tasks.
Read the detailed description
This study is divided in to 2 groups where visually impaired individuals are allocated after inclusion and exlusion criteria.
In this matched-pair randomized study, 40 VI participants aged 6-20 years were allocated to ATP or ATP/S groups. Outcomes were assessed at baseline, immediately post-intervention, and at two-week follow-up using the Patient Hygiene Performance (PHP) index, a 16-step toothbrushing task analysis, and an eight-item oral health knowledge questionnaire. Intra-group changes were analyzed using the Friedman test; inter-group comparisons used the Mann-Whitney U test (p < 0.05).
- Conditions
- Oral Hygiene, Visually Impaired Persons
- Being tested
- ATP, ATP with song
- Keywords
- audio-tactile performance technique, sing along song, tooth brushing task analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATPProcedure or surgery
ATP with standard audio file
ATP with songBehavioural
ATP with informational song used to provide guidance to the participants
| Study group | Role | What they receive |
|---|---|---|
| ATP with audio information file | Active comparator | Participants in this arm receive Oral Hygiene Instruction (OHI) using the standard Audio-Tactile Performance (ATP) technique. This involves hands-on training with a tooth model (dentoform) paired with a pre-recorded audio information file that provides verbal instructions on brushing techniques. Receives: Procedure: ATP |
| ATP with informational song | Experimental | Group B (Intervention Group): Participants in this arm receive OHI using the ATP technique enhanced with a sing-along song. This method utilizes the same hands-on training with a tooth model but replaces the standard audio file with a culturally adapted song containing the brushing instructions, leveraging rhythmic entrainment to aid memory and coordination. Receives: Behavioral: ATP with song |
What is being measured
The primary outcome is the main question the study is designed to answer.
tooth brushing task analysis
The oral cavity is divided into 16 surface areas.
Scoring Criteria: For each area, participants are scored on four specific criteria:
- Maintaining a 45-degree angle of the bristles.
- Using an appropriate back-and-forth vibrating motion.
- Ensuring adequate surface coverage.
- Brushing for at least 5 seconds per surface.
Calculation: Each correctly executed criterion earns 1 point, and the total skill level is determined by the percentage of points achieved out of the total possible points.
Measured: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
Secondary outcomes (1)
Patient hygiene performance (PHP score)
The secondary outcome evaluates the objective effectiveness of the brushing by measuring the amount of dental plaque (debris) left on the teeth.
The Process: Teeth are stained with erythrosin dye, which highlights plaque. Scoring Method: Six specific index teeth are examined, with each tooth surface divided into five sections.
Binary System: A section receives a 1 if debris is present and a 0 if it is absent. Calculation: The final PHP score is the sum of these points divided by the number of surfaces examined; a lower score indicates better oral hygiene.
Measured: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start9 Jun 2025
- Primary completion22 Aug 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesha Shrestha, Mahidol University
- Investigators
- woranun Prapansilp, Masters pediatric dentistry, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585448
- Sponsor's protocol ID
- 61_2025
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals: A Matched-Pair Randomized Study
- ClinicalTrials.gov ID
- NCT07585448
- Acronym / sponsor ID
- 61_2025
- Conditions
- Oral Hygiene, Visually Impaired Persons
- Keywords
- audio-tactile performance technique, sing along song, tooth brushing task analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 13 May 2026 (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.
The goal of this match-pair randomized study is to compare the effectiveness of the standard Audio-Tactile Performance (ATP) technique with a song-based adaptation (ATP/S) in teaching oral hygiene in visually impaired individuals aged 6 to 20 years in Kathmandu, Nepal.
- Can the ATP/S approach achieve a greater improvement in plaque control, as measured by the Patient Hygiene Performance (PHP) index, compared to standard ATP instruction over a two-week period?
- Does the rhythmic structure of a song lead to a more continuous improvement in toothbrushing task performance and theoretical oral health knowledge?
Researchers will compare a control group receiving standard ATP with an audio information file to an intervention group receiving ATP with a sing-along song to see if rhythmic auditory stimuli help regulate sequencing and reduce working-memory demands during complex motor tasks.
Detailed description
This study is divided in to 2 groups where visually impaired individuals are allocated after inclusion and exlusion criteria.
In this matched-pair randomized study, 40 VI participants aged 6-20 years were allocated to ATP or ATP/S groups. Outcomes were assessed at baseline, immediately post-intervention, and at two-week follow-up using the Patient Hygiene Performance (PHP) index, a 16-step toothbrushing task analysis, and an eight-item oral health knowledge questionnaire. Intra-group changes were analyzed using the Friedman test; inter-group comparisons used the Mann-Whitney U test (p < 0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATP with audio information file | Active comparator | Procedure: ATPParticipants in this arm receive Oral Hygiene Instruction (OHI) using the standard Audio-Tactile Performance (ATP) technique. This involves hands-on training with a tooth model (dentoform) paired with a pre-recorded audio information file that provides verbal instructions on brushing techniques. |
| ATP with informational song | Experimental | Behavioral: ATP with songGroup B (Intervention Group): Participants in this arm receive OHI using the ATP technique enhanced with a sing-along song. This method utilizes the same hands-on training with a tooth model but replaces the standard audio file with a culturally adapted song containing the brushing instructions, leveraging rhythmic entrainment to aid memory and coordination. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Bilateral visually impaired in age 6-20yrs. (as verified in school medical record)
Key exclusion criteria (9 listed)
- Visual impairment associated with any disabilities that affected arm motor skill/loss of upper dexterous extremity/abnormal mental development/deaf.
- Using any chemical plaque control agent.
- Individuals with calculus on examining teeth
- On medications that could affect the gingival status.
- Inability to brush due to pain from severe caries/oro-mucosal conditions.
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 |
|---|---|---|
| ATPATP with standard audio file | Procedure or surgery | ATP with audio information file |
| ATP with songATP with informational song used to provide guidance to the participants | Behavioural | ATP with informational song |
Primary outcome
tooth brushing task analysis
Time frame: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
The oral cavity is divided into 16 surface areas. Scoring Criteria: For each area, participants are scored on four specific criteria: 1. Maintaining a 45-degree angle of the bristles. 2. Using an appropriate back-and-forth vibrating motion. 3. Ensuring adequate surface coverage. 4. Brushing for at least 5 seconds per surface. Calculation: Each correctly executed criterion earns 1 point, and the total skill level is determined by the percentage of points achieved out of the total possible points.
1 secondary outcome
Patient hygiene performance (PHP score)
Time frame: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
woranun Prapansilp, Masters pediatric dentistry study director
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATP and ATP with song in people with Oral Hygiene and Visually Impaired Persons, run by Mahidol University at 2 sites in Nepal.
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 9 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. 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?
tooth brushing task analysis (time frame: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)). 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 23 Jun 2026.